Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial (PICASSO)

• ClinicalTrials.gov Identifier: NCT05611242
• Recruitment Status: Recruiting
• First Posted: November 10, 2022
• Last Update Posted: April 24, 2024
• Sponsor: Mercy Health Ohio
• Information provided by (Responsible Party): Dr. Osama O. Zaidat, Mercy Health Ohio

Study Description

Brief Summary:

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Procedure: MT+CAS with IV-AP; Procedure: MT+CAS with PO-AP; Procedure: MT+CAT with PO-AP	Phase 3

Detailed Description:

Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).

Patients presenting with symptoms of AIS in the anterior circulation with proximal carotid occlusion or severe stenosis will be assigned to either:

ARM1 (Control): Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion treatment with non-stenting approach (MT+CAT)

VERSUS

ARM2 (Intervention): Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS)

Randomization will be 1:1

Mechanical thrombectomy and proximal angioplasty or stenting will be performed with an FDA-cleared devices in accordance with the instructions for use (IFU). The order of each procedure (revascularization of the proximal extra-cranial carotid lesion first or after the intracranial lesion) will be left at discretion of the treating proceduralist.

Each treated patient will be followed and assessed for the primary outcome at 3 months and one year after randomization by an independent adjudicator not involved in the procedure. Optional utilization of remote assessment of NIHSS, mRS scale may be provided to selected site

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Independent Investigator-initiated, designed and conducted non-industry study. A prospective, phase III, randomized, open-label, blinded-endpoint controlled trial (PROBE Design).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
• Estimated Study Start Date: May 1, 2024
• Estimated Primary Completion Date: March 1, 2026
• Estimated Study Completion Date: May 1, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: MT+CAT; Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)	Procedure: MT+CAT with PO-AP; Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy; Other Name: Thrombectomy
Experimental: MT+CAS; Acute carotid stenting (ACS) approach constitutes BMM+IAT with acute carotid stenting (ACS) of the extracranial proximal carotid artery, spanning the cervical internal carotid artery (ICA), ICA origin, and the distal common carotid artery (CCA, across the bifurcation) as in the example of left (L) carotid stenting figure below (MT+CAS). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).	Procedure: MT+CAS with IV-AP; Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.; Other Name: Thrombectomy; Procedure: MT+CAS with PO-AP; Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.; Other Name: Thrombectomy

Outcome Measures

Primary Outcome Measures :

1. 90-day Modified Rankin Scale ordinal shift [ Time Frame: Time Frame: 90 days post randomization ]

   Scale used 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. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.

   0 = No symptoms at all.

   1. No significant disability despite symptoms; able to carry out all usual duties and activities.
   2. Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
   3. Moderate disability requiring some help, but able to walk without assistance.
   4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
   5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
   6. Death

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 18 to 79 years of age (before the 80th birthday)
2. Presenting with symptoms consistent with AIS
3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70%
4. NIHSS ≥ 4
5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset
6. Pre-stroke mRS score 0-2
7. Ability to obtain signed informed consent
8. ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume <50 cc quantified by CTP (rCBF<30%) OR <25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between >6h to 16 hours from stroke onset, given the need for antiplatelet therapy.

9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion:

   Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion

10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy

Exclusion Criteria:

1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) despite medication

4. CT evidence of the following conditions:

   • Midline shift or herniation
   • Evidence of intracranial hemorrhage
   • Mass effect with effacement of the ventricles
5. Acute bilateral strokes
6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents.
7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
8. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7 or Partial Thromboplastin Time (PTT) > 3 times of normal
9. Baseline platelet count <100,000 per microliter (μl)
10. Life expectancy less than one year prior to stroke onset
11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes
12. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

Contacts and Locations

Contacts

Contact: Jasmine M Olvany, PhD; (419)-251-4264; jolvany@mercy.com

Contact: Laila Ibrahim, MPH; librahim@mercy.com

Locations

United States, Alabama

Mobile Infirmary Medical Center; Not yet recruiting

Mobile, Alabama, United States, 36607

Contact: Wendy Blount, RN, MSN wendy.blount@infirmaryhealth.org

Principal Investigator: Christopher Southwood, MD

Sub-Investigator: John A Cox, MD

United States, Indiana

Munster Community Hospital; Not yet recruiting

Munster, Indiana, United States, 46321

Contact: Swayamprava Panda, MS, MPhil swayamprava.panda@comhs.org

Principal Investigator: Aamir Badruddin, MD, MBA

Sub-Investigator: Farrukh S. Chaudhry, MD

Sub-Investigator: Sherman H. Chen, MD

United States, Missouri

SSM Health DePaul Hospital; Recruiting

Saint Louis, Missouri, United States, 63044

Contact: Bridget Gatscher, RN bridget.gatscher@ssmhealth.com

Principal Investigator: Amer Alshekhlee, MD

Sub-Investigator: Chizoba Ezepue, MD

United States, Ohio

Mercy Health St. Vincent Medical Center; Recruiting

Toledo, Ohio, United States, 43608

Principal Investigator: Osama O Zaidat, MD, MS

United States, Utah

University of Utah; Not yet recruiting

Salt Lake City, Utah, United States, 84112

Contact: Andrew Grandemange, MBA andrew.grandemange@hsc.utah.edu

Principal Investigator: Ramesh Grandhi, MD, MS

Sub-Investigator: Robert Rennert, MD

Sub-Investigator: Craig Kilburg, MD

Sub-Investigator: Karol Budohoski, MD

United States, West Virginia

West Virginia Univeristy; Recruiting

Morgantown, West Virginia, United States, 26506

Contact: Jennifer Domico, RN jennifer.domico@wvumedicine.org

Principal Investigator: Ansaar T. Rai, MD, MBA

Sub-Investigator: Sohyun Boo, MD

Sub-Investigator: Abdul R. Tarabishy, MD, MS

Sub-Investigator: Phong T Vu, MD

Sub-Investigator: Ryan C. Turner, MD, PhD

Sub-Investigator: Michael Czaplicki, DO

Sponsors and Collaborators

Mercy Health Ohio

Investigators

• Principal Investigator: Osama O Zaidat, MD, MS; Mercy Health St. Vincent Medical Center

More Information

• Responsible Party: Dr. Osama O. Zaidat, Neuroscience and Stroke Medical Director, Mercy Health Ohio
• ClinicalTrials.gov Identifier: NCT05611242
• Other Study ID Numbers: 0525052522
• First Posted: November 10, 2022
• Last Update Posted: April 24, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All shared data will be aggregate.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Dr. Osama O. Zaidat, Mercy Health Ohio:

Stroke; Ischemic Stroke; Thrombectomy

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases