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An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426124
Recruitment Status : Completed
First Posted : February 8, 2018
Results First Posted : February 22, 2023
Last Update Posted : February 22, 2023
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Pulmonary Embolism and Thrombosis
Intervention Device: EkoSonic Endovascular System with thrombolytic
Enrollment 1480
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Period Title: Overall Study
Started 991 489
Completed 941 251
Not Completed 50 238
Arm/Group Title Retrospective Prospective Total
Hide Arm/Group Description

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Total of all reporting groups
Overall Number of Baseline Participants 991 489 1480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 991 participants 489 participants 1480 participants
62.0
(14 to 93)
63.0
(20 to 81)
63.0
(20 to 81)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 991 participants 489 participants 1480 participants
Male
486
  49.0%
259
  53.0%
745
  50.3%
Female
504
  50.9%
230
  47.0%
734
  49.6%
No Answer
1
   0.1%
0
   0.0%
1
   0.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 991 participants 489 participants 1480 participants
Caucasian
652
  65.8%
296
  60.5%
948
  64.1%
African American
192
  19.4%
77
  15.7%
269
  18.2%
Other
13
   1.3%
9
   1.8%
22
   1.5%
Unknown or Missing
134
  13.5%
117
  23.9%
251
  17.0%
Baseline Medical History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 991 participants 489 participants 1480 participants
Active Cancer
79
   8.0%
20
   4.1%
99
   6.7%
BMI ≥30.0 kg/m²
642
  64.8%
319
  65.2%
961
  64.9%
Family History of Venous Thromboembolism
109
  11.0%
71
  14.5%
180
  12.2%
History of Cancer in Remission
116
  11.7%
60
  12.3%
176
  11.9%
Congestive Heart Failure
54
   5.4%
13
   2.7%
67
   4.5%
1.Primary Outcome
Title Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)
Hide Description Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy).
Time Frame Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with matched pairs (pre-procedure echocardiogram and post-procedure echocardiogram through discharge from index hospitalization) have been reported.
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 276 176
Mean (Standard Deviation)
Unit of Measure: Percent change
-22.6  (20.8) -22.6  (19.9)
2.Primary Outcome
Title Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.
Hide Description Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.
Time Frame Post-procedure hospitalization through hospital discharge up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
Continuation of procedure beyond planned time/dose
7
   0.7%
1
   0.2%
Surgical pulmonary embolectomy
0
   0.0%
1
   0.2%
Catheter-assisted embolectomy including thrombus fragmentation or aspiration
5
   0.5%
2
   0.4%
Peripherally administered systemic fibrinolytic therapy
4
   0.4%
0
   0.0%
Other therapy/procedure
40
   4.0%
3
   0.6%
3.Primary Outcome
Title Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.
Hide Description Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.
Time Frame From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
Peripherally administered systemic fibrinolytic therapy
9
   0.9%
1
   0.2%
Surgical pulmonary embolectomy
5
   0.5%
0
   0.0%
Catheter-assisted embolectomy including fragmentation or aspiration
19
   1.9%
0
   0.0%
Other
11
   1.1%
3
   0.6%
4.Primary Outcome
Title Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.
Hide Description Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events.
Time Frame From time of APT procedure through 12 months post-procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs related to EKOS device and/or procedure - Severe
9
   0.9%
5
   1.0%
SAEs related to EKOS device and/or procedure - Moderate
6
   0.6%
1
   0.2%
SAEs related to EKOS device and/or procedure - Mild
1
   0.1%
0
   0.0%
5.Primary Outcome
Title All-cause Mortality During First 12 Months Post-procedure.
Hide Description Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
Time Frame Start of procedure through 12 months post-procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
Retrospective data to be updated.
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
50
   5.0%
15
   3.1%
6.Primary Outcome
Title Healthcare Utilization
Hide Description Summary of healthcare utilization from date of enrollment through discharge.
Time Frame Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 483
Median (Inter-Quartile Range)
Unit of Measure: Hours
44.2
(27.3 to 64.6)
41.2
(25.8 to 54.3)
7.Primary Outcome
Title Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits
Hide Description Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome.
Time Frame Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.
Hide Outcome Measure Data
Hide Analysis Population Description
QOL date were not collected in the retrospective cohort. These questionnaires were only collected prospectively.
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 0 243
Mean (Standard Deviation)
Unit of Measure: percentage change
PEmb-QOL Mean Change at 3 Months -22.52  (24.12)
PEmb-QOL Mean Change at 12 Months -23.74  (24.14)
8.Primary Outcome
Title Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits.
Hide Description

Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months.

The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome.

The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome.

Time Frame Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.
Hide Outcome Measure Data
Hide Analysis Population Description
Data for the retrospective cohort were not captured as Quality of Life questionnaires were not Standard of Care at most institutions.
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 0 483
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change in VAS at 3 Months Number Analyzed 0 participants 242 participants
12.4  (24.36)
Change in VAS at 12 Months Number Analyzed 0 participants 152 participants
11.1  (21.7)
Change in Utility Score at 3 Months Number Analyzed 0 participants 243 participants
0.20  (0.35)
Change in Utility Score at 12 Months Number Analyzed 0 participants 152 participants
0.19  (0.31)
Change in Misery Score at 3 Months Number Analyzed 0 participants 243 participants
-2.8  (4.8)
Change in Misery Score at 12 Months Number Analyzed 0 participants 152 participants
-2.7  (4.3)
9.Primary Outcome
Title Number of Patients Needing an IVC Filter Placement
Hide Description Measured by number patients with an occurrence of needing an IVC filter placement.
Time Frame From date of procedure through 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 483
Measure Type: Count of Participants
Unit of Measure: Participants
50
   5.0%
20
   4.1%
10.Primary Outcome
Title Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity
Hide Description Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe).
Time Frame From post-procedure through 12-months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
Major Bleeds within 365 days - Mild
10
   1.0%
3
   0.6%
Major Bleeds within 365 days - Moderate
33
   3.3%
8
   1.6%
Major Bleeds within 365 days - Severe
18
   1.8%
3
   0.6%
11.Primary Outcome
Title Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.
Hide Description Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
Time Frame From post-procedure through 12-months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
VTEs within 365 Days - Mild
33
   3.3%
31
   6.3%
VTEs within 365 Days - Moderate
15
   1.5%
11
   2.2%
VTEs within 365 Days - Severe
15
   1.5%
5
   1.0%
12.Primary Outcome
Title Diagnosis of Pulmonary Hypertension Diagnosis
Hide Description New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE.
Time Frame Analyzed 12 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description:

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Overall Number of Participants Analyzed 991 489
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   0.2%
Time Frame Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit.
Adverse Event Reporting Description Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.
 
Arm/Group Title Retrospective Prospective
Hide Arm/Group Description

Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion.

EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

All-Cause Mortality
Retrospective Prospective
Affected / at Risk (%) Affected / at Risk (%)
Total   50/991 (5.05%)   15/489 (3.07%) 
Hide Serious Adverse Events
Retrospective Prospective
Affected / at Risk (%) Affected / at Risk (%)
Total   100/991 (10.09%)   39/489 (7.98%) 
Blood and lymphatic system disorders     
Anaemia  1  4/991 (0.40%)  0/489 (0.00%) 
Thrombocytopenia  1  1/991 (0.10%)  0/489 (0.00%) 
Cardiac disorders     
Atrial Fibrillation  1  0/991 (0.00%)  0/489 (0.00%) 
Atroventricular block, complete  1  1/991 (0.10%)  0/489 (0.00%) 
Bradycardia  1  1/991 (0.10%)  0/489 (0.00%) 
Cardiac arrest  1  10/991 (1.01%)  0/489 (0.00%) 
Cardiac tamponade  1  0/991 (0.00%)  1/489 (0.20%) 
Cardiogenic shock  1  1/991 (0.10%)  0/489 (0.00%) 
Dyspnoea  1  0/991 (0.00%)  1/489 (0.20%) 
Endocarditis, bacterial  1  1/991 (0.10%)  0/489 (0.00%) 
Pulseless electrical activity  1  3/991 (0.30%)  0/489 (0.00%) 
Reperfusion arrhythmia  1  1/991 (0.10%)  0/489 (0.00%) 
Right ventricular failure  1  1/991 (0.10%)  0/489 (0.00%) 
Gastrointestinal disorders     
Diverticulum  1  1/991 (0.10%)  0/489 (0.00%) 
Gastrointestinal hemorrhage  1  0/991 (0.00%)  1/489 (0.20%) 
General disorders     
Death  1  3/991 (0.30%)  5/489 (1.02%) 
Multiple organ dysfunction syndrome  1  1/991 (0.10%)  2/489 (0.41%) 
Infections and infestations     
Pneumonia  1  0/991 (0.00%)  1/489 (0.20%) 
Sepsis  1  2/991 (0.20%)  0/489 (0.00%) 
Soft tissue infection  1  0/991 (0.00%)  1/489 (0.20%) 
Injury, poisoning and procedural complications     
Gun shot wound  1  0/991 (0.00%)  1/489 (0.20%) 
Traumatic haematoma  1  1/991 (0.10%)  0/489 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma  1  0/991 (0.00%)  1/489 (0.20%) 
Astrocytoma  1  1/991 (0.10%)  0/489 (0.00%) 
Colon cancer, metastatic  1  1/991 (0.10%)  0/489 (0.00%) 
Gastric cancer  1  1/991 (0.10%)  1/489 (0.20%) 
Lung adenocarcinoma  1  0/991 (0.00%)  1/489 (0.20%) 
Lung cancer, metastatic  1  1/991 (0.10%)  0/489 (0.00%) 
Metastatic renal cell carcinoma  1  1/991 (0.10%)  0/489 (0.00%) 
Neoplasm, malignant  1  0/991 (0.00%)  2/489 (0.41%) 
Neuroendocrine tumor  1  1/991 (0.10%)  0/489 (0.00%) 
Ovarian cancer  1  1/991 (0.10%)  0/489 (0.00%) 
Small cell lung cancer  1  1/991 (0.10%)  0/489 (0.00%) 
Transitional cell carcinoma  1  1/991 (0.10%)  0/489 (0.00%) 
Nervous system disorders     
Subdural haematoma  1  1/991 (0.10%)  0/489 (0.00%) 
Psychiatric disorders     
Delirium  1  1/991 (0.10%)  0/489 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/991 (0.10%)  0/489 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/991 (0.00%)  1/489 (0.20%) 
Cardio-respiratory arrest  1  2/991 (0.20%)  1/489 (0.20%) 
Chronic pulmonary obstructive disease  1  1/991 (0.10%)  0/489 (0.00%) 
Pulmonary embolism  1  0/991 (0.00%)  1/489 (0.20%) 
Pulmonary haemorrhage  1  1/991 (0.10%)  0/489 (0.00%) 
Respiratory failure  1  2/991 (0.20%)  0/489 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/991 (0.10%)  0/489 (0.00%) 
Vascular disorders     
Abdominal wall haemorrhage  1  1/991 (0.10%)  0/489 (0.00%) 
Acute myocardial infarction  1  1/991 (0.10%)  1/489 (0.20%) 
Cardiogenic shock  1  2/991 (0.20%)  0/489 (0.00%) 
Cerebellar haemorrhage  1  1/991 (0.10%)  0/489 (0.00%) 
Cerebral haemorrhage  1  2/991 (0.20%)  0/489 (0.00%) 
Cerebral infarction  1  1/991 (0.10%)  0/489 (0.00%) 
Cerebrovascular accident  1  1/991 (0.10%)  0/489 (0.00%) 
Compartment syndrome  1  0/991 (0.00%)  1/489 (0.20%) 
Deep vein thrombosis  1  5/991 (0.50%)  1/489 (0.20%) 
Disseminated intravascular coagulation  1  2/991 (0.20%)  0/489 (0.00%) 
Embolism, venous  1  1/991 (0.10%)  1/489 (0.20%) 
Gastrointestinal haemorrhage  1  5/991 (0.50%)  1/489 (0.20%) 
Haematochezia  1  1/991 (0.10%)  0/489 (0.00%) 
Haematoma  1  7/991 (0.71%)  0/489 (0.00%) 
Haematuria  1  1/991 (0.10%)  1/489 (0.20%) 
Haemoptysis  1  0/991 (0.00%)  1/489 (0.20%) 
Haemorrhage  1  1/991 (0.10%)  0/489 (0.00%) 
Haemorrhage, intracranial  1  3/991 (0.30%)  0/489 (0.00%) 
Heparin-induced thrombocytopenia  1  1/991 (0.10%)  0/489 (0.00%) 
Hypotension  1  1/991 (0.10%)  0/489 (0.00%) 
Hypoxic-ischaemic encephalopathy  1  1/991 (0.10%)  0/489 (0.00%) 
Internal haemorrhage  1  1/991 (0.10%)  0/489 (0.00%) 
Lacunar infarction  1  1/991 (0.10%)  0/489 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/991 (0.10%)  1/489 (0.20%) 
Peripheral arterial occlusive disease  1  1/991 (0.10%)  0/489 (0.00%) 
Post procedural haematoma  1  1/991 (0.10%)  0/489 (0.00%) 
Post procedural haemorrhage  1  2/991 (0.20%)  0/489 (0.00%) 
Pulmonary embolism  1  12/991 (1.21%)  7/489 (1.43%) 
Pulmonary hypertension  1  1/991 (0.10%)  2/489 (0.41%) 
Retroperitoneal haematoma  1  1/991 (0.10%)  0/489 (0.00%) 
Retroperitoneal haemorrhage  1  0/991 (0.00%)  1/489 (0.20%) 
Shock, hemorrhagic  1  1/991 (0.10%)  0/489 (0.00%) 
Subdural haematoma  1  1/991 (0.10%)  1/489 (0.20%) 
Transient ischaemic attack  1  1/991 (0.10%)  0/489 (0.00%) 
Vaginal hemorrhage  1  1/991 (0.10%)  1/489 (0.20%) 
Vascular access site haematoma  1  0/991 (0.00%)  1/489 (0.20%) 
Vascular pseudoaneurysm  1  1/991 (0.10%)  0/489 (0.00%) 
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Retrospective Prospective
Affected / at Risk (%) Affected / at Risk (%)
Total   63/991 (6.36%)   40/489 (8.18%) 
Vascular disorders     
Deep Vein Thrombosis  1  39/991 (3.94%)  34/489 (6.95%) 
Haematoma  1  24/991 (2.42%)  6/489 (1.23%) 
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Leslie Cass
Organization: Boston Scientific
Phone: 206-641-4529
EMail: Leslie.Cass@bsci.com
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03426124    
Other Study ID Numbers: BTG-001653-01
First Submitted: January 29, 2018
First Posted: February 8, 2018
Results First Submitted: October 6, 2021
Results First Posted: February 22, 2023
Last Update Posted: February 22, 2023