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SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT2)

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ClinicalTrials.gov Identifier: NCT03876457
Recruitment Status : Completed
First Posted : March 15, 2019
Results First Posted : March 15, 2024
Last Update Posted : March 15, 2024
Sponsor:
Collaborators:
Stryker Neurovascular
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Amrou Sarraj, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Ischemic Stroke
Interventions Device: Endovascular Thrombectomy
Other: Medical Management
Enrollment 352
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.

 Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Period Title: Overall Study
Started 178 174
Completed 177 171
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             3
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management Total
Hide Arm/Group Description

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.

 Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients. Total of all reporting groups
Overall Number of Baseline Participants 178 174 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants 174 participants 352 participants
65.1  (12.7) 65.3  (12.6) 65.2  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 174 participants 352 participants
Female
71
  39.9%
74
  42.5%
145
  41.2%
Male
107
  60.1%
100
  57.5%
207
  58.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 174 participants 352 participants
Hispanic or Latino
29
  16.3%
31
  17.8%
60
  17.0%
Not Hispanic or Latino
136
  76.4%
134
  77.0%
270
  76.7%
Unknown or Not Reported
13
   7.3%
9
   5.2%
22
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants 174 participants 352 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
1
   0.3%
Asian
5
   2.8%
3
   1.7%
8
   2.3%
Native Hawaiian or Other Pacific Islander
2
   1.1%
0
   0.0%
2
   0.6%
Black or African American
26
  14.6%
24
  13.8%
50
  14.2%
White
132
  74.2%
130
  74.7%
262
  74.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
   7.3%
16
   9.2%
29
   8.2%
1.Primary Outcome
Title Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
Hide Description

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Median (95% Confidence Interval)
Unit of Measure: scores on a scale
4
(3 to 6)
5
(4 to 6)
2.Secondary Outcome
Title Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
Hide Description

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
36
  20.3%
12
   7.0%
3.Secondary Outcome
Title Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
Hide Description

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.

Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.

Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.

Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.

Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.

Score 6: Dead
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
67
  37.9%
32
  18.7%
4.Secondary Outcome
Title Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
2
   1.1%
5.Secondary Outcome
Title Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
44
  24.7%
27
  15.5%
6.Secondary Outcome
Title Number of Mortalities Within 90-day Follow-up
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 177 171
Measure Type: Number
Unit of Measure: Mortalities
68 71
7.Secondary Outcome
Title Number of Procedural Complications
Hide Description

The following were included in the complications counted:

  • Surgical site hematoma
  • Surgical site infection
  • Vascular injury (peripheral or intracranial dissection, perforation or others) caused by the endovascular procedure
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in the medical management group did not undergo procedure so no data was collected for that group.
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 0
Measure Type: Number
Unit of Measure: Procedural complications
30
8.Secondary Outcome
Title Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
Hide Description [Not Specified]
Time Frame at the end of endovascular thrombectomy procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Data was only collected for the Endovascular Thrombectomy plus Medical Management group
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 0
Measure Type: Number
Unit of Measure: Successful reperfusions
142
9.Secondary Outcome
Title Discharge Location
Hide Description [Not Specified]
Time Frame day 5-7 after randomization/at discharge (whichever is later)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
Discharged to home
19
  10.7%
10
   5.7%
Discharged to acute care facility
11
   6.2%
16
   9.2%
Discharged to inpatient rehab facility
72
  40.4%
65
  37.4%
Discharged to skilled nursing facility
23
  12.9%
20
  11.5%
Discharged to hospice or home hospice
11
   6.2%
19
  10.9%
Discharged to in-hospital death
42
  23.6%
44
  25.3%
10.Secondary Outcome
Title Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of ≥8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
4 participants in the Endovascular Thrombectomy plus medical management, and 1 participant in the medical management group did not have enough data available to be included in the analysis.
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 174 172
Measure Type: Count of Participants
Unit of Measure: Participants
20
  11.5%
13
   7.6%
11.Secondary Outcome
Title Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
Hide Description The Neurological Quality of Life score (NeuroQoL) is a patient-reported outcome measure that assesses the impact of neurological disorders on various aspects of a person's quality of life in neurological diseases and has measures developed across 17 different domains. The trial measured NeuroQoL scores for Mobility, Depression, Social and Cognitive domains. The scores provide a measure of an individual's quality of life in a given domain relative to a reference population, with a mean score of 50 and range of 0-100. A t-score of 50 indicates average quality of life, while scores above 50 indicate better-than-average quality of life and scores below 50 indicate poorer-than-average quality of life, except for depression domain - where lower scores indicate better and higher scores indicate worse quality of life.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 177 171
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Mobility domain
35.2
(23.9 to 43.9)
25.1
(16.5 to 33.0)
Depression domain
47.9
(43.1 to 54.3)
53.6
(46.8 to 57.4)
Social domain
37.1
(32.7 to 42.0)
33.5
(27.7 to 37.8)
Cognitive domain
41.9
(35.0 to 49.6)
37.9
(30.9 to 42.9)
12.Secondary Outcome
Title The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) 24 Hours to 7 Days After Randomization
Hide Description [Not Specified]
Time Frame 24 hours to 7 days
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Lesion Growth Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume
Hide Description [Not Specified]
Time Frame 24 hours to 7 days
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Number of Participants Who Suffered Parenchymal Hemorrhage Type 2
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
1
   0.6%
19.Other Pre-specified Outcome
Title Number of Participants Who Suffered a Subarachnoid Hemorrhage
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.2%
0
   0.0%
20.Other Pre-specified Outcome
Title Number of Participants Who Had a Hemicraniectomy During Index Hospitalization
Hide Description [Not Specified]
Time Frame day 5-7 after randomization/at discharge (whichever is later)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Measure Type: Count of Participants
Unit of Measure: Participants
29
  16.3%
26
  14.9%
21.Other Pre-specified Outcome
Title Length of Hospital Stay
Hide Description Was assessed if the patient was discharged at every follow-up visit to determine the length of the stay if the patient was not discharged at the time of previous follow-up visit.
Time Frame Up to 90-day follow up visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description:

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.
Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
Overall Number of Participants Analyzed 178 174
Median (Inter-Quartile Range)
Unit of Measure: Days
9
(5 to 17)
8
(5 to 13)
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovascular Thrombectomy Plus Medical Management Medical Management
Hide Arm/Group Description

Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. Treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices used are FDA-approved: Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with/without aspiration, is left up to the interventionalist.

Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols.

 Medical Management: Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
All-Cause Mortality
Endovascular Thrombectomy Plus Medical Management Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   68/178 (38.20%)   71/174 (40.80%) 
Hide Serious Adverse Events
Endovascular Thrombectomy Plus Medical Management Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   129/178 (72.47%)   123/174 (70.69%) 
Cardiac disorders     
Endocarditis †  0/178 (0.00%)  1/174 (0.57%) 
Heart failure †  7/178 (3.93%)  8/174 (4.60%) 
Myocardial infarction †  2/178 (1.12%)  3/174 (1.72%) 
Pericardial effusion †  1/178 (0.56%)  0/174 (0.00%) 
Endocrine disorders     
Hyperglycemic Hyperosmolar State †  0/178 (0.00%)  1/174 (0.57%) 
Infections and infestations     
Sepsis, Systemic inflammatory response syndrome †  11/178 (6.18%)  9/174 (5.17%) 
Nervous system disorders     
Cerebral Edema with Midline Shift †  64/178 (35.96%)  57/174 (32.76%) 
Cerebritis †  1/178 (0.56%)  0/174 (0.00%) 
Delirium, Cognitive Dysfunction †  9/178 (5.06%)  5/174 (2.87%) 
Neurological Deterioration †  44/178 (24.72%)  27/174 (15.52%) 
New Stroke †  6/178 (3.37%)  5/174 (2.87%) 
Progression of Disease, Palliative Care Decision †  25/178 (14.04%)  31/174 (17.82%) 
Symptomatic Intracranial Hemorrhage †  1/178 (0.56%)  2/174 (1.15%) 
Renal and urinary disorders     
Acute kidney injury †  9/178 (5.06%)  9/174 (5.17%) 
Urinary Tract Infection †  12/178 (6.74%)  13/174 (7.47%) 
Reproductive system and breast disorders     
Respiratory failure †  30/178 (16.85%)  19/174 (10.92%) 
Respiratory, thoracic and mediastinal disorders     
COVID-19 †  5/178 (2.81%)  5/174 (2.87%) 
Lower respiratory infection (pneumonia) †  18/178 (10.11%)  21/174 (12.07%) 
Pulmonary embolism †  4/178 (2.25%)  3/174 (1.72%) 
Skin and subcutaneous tissue disorders     
Wound Infection †  0/178 (0.00%)  2/174 (1.15%) 
Vascular disorders     
Access Site Complication - Arterial Occlusion †  3/178 (1.69%)  0/174 (0.00%) 
Access Site Complication - Hematoma †  1/178 (0.56%)  0/174 (0.00%) 
Access Site Complication - Infection †  1/178 (0.56%)  0/174 (0.00%) 
Acute Arterial Occlusion (Acute Limb Ischemia) †  2/178 (1.12%)  1/174 (0.57%) 
Deep Vein Thrombosis †  2/178 (1.12%)  2/174 (1.15%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endovascular Thrombectomy Plus Medical Management Medical Management
Affected / at Risk (%) Affected / at Risk (%)
Total   77/178 (43.26%)   59/174 (33.91%) 
Blood and lymphatic system disorders     
Anemia †  8/178 (4.49%)  4/174 (2.30%) 
Splenic infarct †  1/178 (0.56%)  0/174 (0.00%) 
Thrombocytopenia †  4/178 (2.25%)  0/174 (0.00%) 
Cardiac disorders     
Cardiac Arrythmia †  21/178 (11.80%)  20/174 (11.49%) 
Hallucination †  1/178 (0.56%)  0/174 (0.00%) 
Hypertension †  1/178 (0.56%)  3/174 (1.72%) 
Hypotension †  4/178 (2.25%)  1/174 (0.57%) 
near syncopal episode †  1/178 (0.56%)  0/174 (0.00%) 
Ear and labyrinth disorders     
Tinnitus †  1/178 (0.56%)  0/174 (0.00%) 
Endocrine disorders     
Syndrome of inappropriate ADH production †  1/178 (0.56%)  0/174 (0.00%) 
Eye disorders     
Eye Complications †  2/178 (1.12%)  0/174 (0.00%) 
ocular nerve damage †  1/178 (0.56%)  0/174 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Complications †  19/178 (10.67%)  8/174 (4.60%) 
Ileus †  1/178 (0.56%)  0/174 (0.00%) 
Lactose intolerance reaction †  1/178 (0.56%)  0/174 (0.00%) 
General disorders     
Alcohol Withdrawal †  1/178 (0.56%)  1/174 (0.57%) 
Dehydration †  1/178 (0.56%)  0/174 (0.00%) 
Diaphoresis †  1/178 (0.56%)  1/174 (0.57%) 
Dizziness †  1/178 (0.56%)  0/174 (0.00%) 
Fall †  2/178 (1.12%)  4/174 (2.30%) 
Fever †  7/178 (3.93%)  9/174 (5.17%) 
Headache †  9/178 (5.06%)  2/174 (1.15%) 
Insomnia †  3/178 (1.69%)  0/174 (0.00%) 
Lethargy †  4/178 (2.25%)  4/174 (2.30%) 
Nausea †  4/178 (2.25%)  2/174 (1.15%) 
Thirst †  1/178 (0.56%)  0/174 (0.00%) 
Hepatobiliary disorders     
Liver Injury †  5/178 (2.81%)  1/174 (0.57%) 
Immune system disorders     
Laryngeal Edema †  1/178 (0.56%)  0/174 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Complications †  9/178 (5.06%)  6/174 (3.45%) 
Nervous system disorders     
Asymptomatic Intracranial Hemorrhage †  0/178 (0.00%)  1/174 (0.57%) 
Carotid Cavernous Fistula †  1/178 (0.56%)  0/174 (0.00%) 
Cerebral Vasospasm †  1/178 (0.56%)  0/174 (0.00%) 
Clonus †  1/178 (0.56%)  0/174 (0.00%) 
Encephalopathy †  1/178 (0.56%)  1/174 (0.57%) 
Epidural Hemorrhage †  0/178 (0.00%)  1/174 (0.57%) 
Evolution of infarction on the brain imaging †  8/178 (4.49%)  8/174 (4.60%) 
Progression of Disease †  16/178 (8.99%)  11/174 (6.32%) 
SDH †  1/178 (0.56%)  0/174 (0.00%) 
Seizures †  2/178 (1.12%)  2/174 (1.15%) 
Tremors †  0/178 (0.00%)  1/174 (0.57%) 
Vessel dissection †  4/178 (2.25%)  0/174 (0.00%) 
Vessel perforation †  2/178 (1.12%)  0/174 (0.00%) 
Psychiatric disorders     
Anxiety †  0/178 (0.00%)  1/174 (0.57%) 
Depression †  3/178 (1.69%)  0/174 (0.00%) 
Renal and urinary disorders     
Other Renal Complications †  14/178 (7.87%)  7/174 (4.02%) 
Reproductive system and breast disorders     
Uterine hemorrhage †  1/178 (0.56%)  0/174 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion †  4/178 (2.25%)  2/174 (1.15%) 
Upper Respiratory Infection †  7/178 (3.93%)  0/174 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Complications †  10/178 (5.62%)  1/174 (0.57%) 
Vascular disorders     
Epistaxis †  2/178 (1.12%)  0/174 (0.00%) 
Hematoma †  2/178 (1.12%)  1/174 (0.57%) 
Non-Cerebral Thrombotic Events †  5/178 (2.81%)  1/174 (0.57%) 
Stent Thrombosis †  1/178 (0.56%)  0/174 (0.00%) 
Symptomatic Carotid Artery Stenosis †  0/178 (0.00%)  1/174 (0.57%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amrou Sarraj
Organization: University Hospitals Cleveland Medical Center
Phone: (216)844-0474
EMail: Amrou.Sarraj@UHhospitals.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amrou Sarraj, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03876457    
Other Study ID Numbers: G180275, Pro00056862
First Submitted: March 8, 2019
First Posted: March 15, 2019
Results First Submitted: November 20, 2023
Results First Posted: March 15, 2024
Last Update Posted: March 15, 2024