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

December 11, 2025 updated by: Dr. Osama O. Zaidat, Mercy Health Ohio
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

404

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Recruiting
        • Mobile Infirmary Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher Southwood, MD
        • Sub-Investigator:
          • John A Cox, MD
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Glendale Adventist Medical Center
        • Contact:
        • Principal Investigator:
          • Mikayel Grigoryan, MD
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
        • Principal Investigator:
          • Shuichi Suzuki, MD
        • Sub-Investigator:
          • Jessica Campos, MD
      • Pomona, California, United States, 91767
        • Recruiting
        • Pomona Valley
        • Contact:
        • Principal Investigator:
          • Nazli Janjua, MD
      • Sacramento, California, United States, 95816
        • Not yet recruiting
        • Sutter Institute for Medical Research
        • Contact:
        • Principal Investigator:
          • Matthew Alexander, MD
        • Sub-Investigator:
          • Manoj Mittal, MD
      • San Francisco, California, United States, 94107
        • Recruiting
        • California Pacific Medical Center/Mils Peninsula Medical Center
        • Principal Investigator:
          • Fabio Settecase, MD
        • Contact:
        • Sub-Investigator:
          • Joey English, MD
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton - Baptist Health
        • Principal Investigator:
          • Brian Snelling, MD
        • Contact:
        • Sub-Investigator:
          • Farrah Wolf, MD
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Delray Medical Center
        • Contact:
        • Principal Investigator:
          • Nils Muller-Kronast, MD
        • Sub-Investigator:
          • Dennys Reyes, MD
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Research Institute
        • Sub-Investigator:
          • Daniel Ikeda, MD
        • Sub-Investigator:
          • Eric Sauvageau, MD
        • Contact:
        • Principal Investigator:
          • Nima Amin Aghaebrahim, MD
        • Sub-Investigator:
          • Ricardo Hanel, MD, PhD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida Health Jacksonville
        • Contact:
        • Principal Investigator:
          • Yazan Radaideh, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami School of Medicine
        • Sub-Investigator:
          • Negar Asdaghi, MD
        • Contact:
        • Principal Investigator:
          • DileepA Yavagal, MD
        • Sub-Investigator:
          • Luis Guada, MD
        • Sub-Investigator:
          • Aaron Rodriguez, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health, Inc.
        • Principal Investigator:
          • Marshall Cress, MD
        • Contact:
        • Sub-Investigator:
          • Paul Foreman, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Waldo R Guerrero, MD
        • Sub-Investigator:
          • Kunal Vakharia, MD
        • Sub-Investigator:
          • Maxim Mokin, MD, PhD
        • Sub-Investigator:
          • Sheyar Amin, MD
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • St. Mary's Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel Vela-Duarte, MD
        • Sub-Investigator:
          • Ali Malek, MD
        • Sub-Investigator:
          • Muneer Hassan, MD
        • Sub-Investigator:
          • Juan Ramos-Canseco, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare
        • Principal Investigator:
          • Michael Stiefel, MD
        • Contact:
        • Sub-Investigator:
          • Jesse Schuette, MD
      • Marietta, Georgia, United States, 30062
        • Recruiting
        • WellStar Health System, Inc
        • Contact:
        • Principal Investigator:
          • Juan Carlos Martinez-Gutierrez, MD
        • Sub-Investigator:
          • Rishi Gupta, MD
        • Sub-Investigator:
          • William Humphries, MD
        • Sub-Investigator:
          • Ahmad Khaldi, MD
        • Sub-Investigator:
          • Ovais Inamullah, MD
        • Sub-Investigator:
          • Kumiko Owada, MD
        • Sub-Investigator:
          • Frances Fan, MD
        • Sub-Investigator:
          • Meghan K Purohit, DO
        • Sub-Investigator:
          • Amreen Farooqui, MD
        • Sub-Investigator:
          • Ashis Tayal, MD
        • Sub-Investigator:
          • Kyle Grubbs, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Tareq Kass-Hout, MD
        • Contact:
        • Sub-Investigator:
          • Michael Hurley, MD
      • Chicago, Illinois, United States, 60606
        • Recruiting
        • Ascension/Alexian Brothers Health System
        • Principal Investigator:
          • Kaiz Asif, MD
        • Contact:
        • Sub-Investigator:
          • Timothy Malisch, MD
        • Sub-Investigator:
          • Scott Geraghty, MD
        • Sub-Investigator:
          • Megan Kosrow, NP
        • Sub-Investigator:
          • Amanda Benjamin, NP
        • Sub-Investigator:
          • Colleen Grandowski, NP
        • Sub-Investigator:
          • Kelly Morris, RN
        • Sub-Investigator:
          • Christina Gavoni, APRN
      • Winfield, Illinois, United States, 60190
        • Recruiting
        • Northwestern Medicine Central DuPage Hospital
        • Principal Investigator:
          • Dhruvil Pandya, MD
        • Contact:
        • Sub-Investigator:
          • Harish Shownkeen, MD
        • Sub-Investigator:
          • Avi Mazumdar, MD
        • Sub-Investigator:
          • Bryan Fill, APRN
        • Sub-Investigator:
          • Eva Chwastowska
        • Sub-Investigator:
          • Izabela Holanday, PA
        • Sub-Investigator:
          • Jennifer Cropsey, APRN
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Methodist Hospital
        • Principal Investigator:
          • Kaustubh Limaye, MD
        • Contact:
        • Sub-Investigator:
          • Bradley Bohnstedt, MD
        • Sub-Investigator:
          • Ann Jones, MD
        • Sub-Investigator:
          • Rajat Kapoor, MD
        • Sub-Investigator:
          • Richard Scheer, MD
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Munster Community Hospital
        • Contact:
        • Principal Investigator:
          • Aamir Badruddin, MD, MBA
        • Sub-Investigator:
          • Farrukh S. Chaudhry, MD
        • Sub-Investigator:
          • Sherman H. Chen, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Abraham, MD
        • Sub-Investigator:
          • Koji Ebersole
        • Sub-Investigator:
          • Ernest Madarang
        • Sub-Investigator:
          • Jeremy Peterson, MD
        • Sub-Investigator:
          • Alan Reeves, MD
        • Sub-Investigator:
          • Tiffany Barkley, DO
        • Sub-Investigator:
          • Prasanna Eswaradass, MD
        • Sub-Investigator:
          • Laith Maali, MD
        • Sub-Investigator:
          • Lee Rosterman, DO
        • Sub-Investigator:
          • Sabreena Slavin, MD
        • Sub-Investigator:
          • Colleen Lechtenberg, MD
        • Sub-Investigator:
          • Jorge Kawano-Castillo, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40299
        • Recruiting
        • Baptist Healthcare Systems, Inc
        • Principal Investigator:
          • Curtis Given, MD
        • Contact:
        • Sub-Investigator:
          • Ben Newman, MD
        • Sub-Investigator:
          • Nicholas Villelli, MD
        • Sub-Investigator:
          • Christian Ramsey, MD
        • Sub-Investigator:
          • Murali Kolikonda, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Contact:
        • Principal Investigator:
          • Shail Thanki, MD
        • Sub-Investigator:
          • Alicia Nicklas, NP
        • Sub-Investigator:
          • Mohammad AlMajali, MD
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Health Sciences Center at Shreveport
        • Principal Investigator:
          • Hugo Cuellar-Saenz, MD
        • Contact:
        • Sub-Investigator:
          • Himanshu Chokhawala, MD
        • Sub-Investigator:
          • Pankaj Sharma, MD
        • Sub-Investigator:
          • Rahul Shah, MD
        • Sub-Investigator:
          • Amey Savardekar, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Thanh Nguyen, MD
        • Contact:
        • Sub-Investigator:
          • Mohamad Abdalkader, MD
        • Sub-Investigator:
          • Jose Romero, MD
        • Sub-Investigator:
          • Steven Feske, MD
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts
        • Contact:
        • Principal Investigator:
          • Jasmeet Singh, MD
    • Michigan
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Flint
        • Contact:
        • Principal Investigator:
          • Aniel Majjhoo, MD
        • Sub-Investigator:
          • Mahmoud Rayes, MD
        • Sub-Investigator:
          • Bharath Naravelta, MD
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
        • Contact:
        • Principal Investigator:
          • Larry Morgan, DO
        • Sub-Investigator:
          • Kenneth Liu, MD
        • Sub-Investigator:
          • Kelly Becker, NP
        • Sub-Investigator:
          • Tatiana Burkholder, NP
        • Sub-Investigator:
          • Katharine Gross, NP
        • Sub-Investigator:
          • Lisa Carolan-Katz, NP
        • Sub-Investigator:
          • Timothy Carew, NP
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Michigan State University
        • Principal Investigator:
          • Anmar Razak, MD
        • Contact:
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • McLaren Macomb
        • Principal Investigator:
          • Aniel Majjhoo, MD
        • Sub-Investigator:
          • Mahmoud Rayes, MD
        • Contact:
        • Sub-Investigator:
          • Bharath Naravetla, MD
    • Missouri
      • St Louis, Missouri, United States, 63044
        • Recruiting
        • SSM Health DePaul Hospital
        • Principal Investigator:
          • Amer Alshekhlee, MD
        • Contact:
        • Sub-Investigator:
          • Chizoba Ezepue, MD
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Recruiting
        • JFK University Medical Center
        • Sub-Investigator:
          • Brian Jankowitz, MD
        • Sub-Investigator:
          • Pankaj Sharma, MD
        • Contact:
        • Principal Investigator:
          • Haralabos Zacharatos, DO
        • Sub-Investigator:
          • Suanne Fleyzor, FNP-C
        • Sub-Investigator:
          • Nancy Gadallah, DO
        • Sub-Investigator:
          • Arifa Ghori, MD
        • Sub-Investigator:
          • Joshua Haimi, MD
        • Sub-Investigator:
          • Brigitte Percival, FNP-C
        • Sub-Investigator:
          • Sean Scarpiello, MD
        • Sub-Investigator:
          • Thomas Snyder, MD
        • Sub-Investigator:
          • Sara Strauss, DO
      • Piscataway, New Jersey, United States, 08854
        • Recruiting
        • Rutgers, The State University
        • Principal Investigator:
          • Priyank Khandelwal, MD
        • Contact:
        • Sub-Investigator:
          • Amit Singla, MD
        • Sub-Investigator:
          • Anurag Sahoo, MD
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Principal Investigator:
          • Alexandra Paul, MD
        • Contact:
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health- South Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Richard Jung, MD
        • Sub-Investigator:
          • Jeffrey Katz, MD
        • Sub-Investigator:
          • Kevin Atul Shah, MD
        • Sub-Investigator:
          • Casey McCall, PA
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Hazem Shoirah, MD
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Stacey Wolfe, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Contact:
        • Principal Investigator:
          • Nirav Vora, MD
        • Sub-Investigator:
          • Brian Katz, MD
        • Sub-Investigator:
          • Aaron Loochtan, DO
        • Sub-Investigator:
          • Leanne Lin, MD
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health St. Vincent Medical Center
        • Principal Investigator:
          • Osama O Zaidat, MD, MS
        • Contact:
        • Sub-Investigator:
          • Eugene Lin, MD
        • Sub-Investigator:
          • Yazan Ashouri, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Hakeem Shakir, MD
        • Contact:
        • Sub-Investigator:
          • Andrew Bauer, MD
        • Sub-Investigator:
          • Shyian Jen, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network Research Institute
        • Contact:
        • Principal Investigator:
          • Evan Luther, MD
        • Sub-Investigator:
          • Russell Cerejo, MD
        • Sub-Investigator:
          • Scott Rudkin, MD
        • Sub-Investigator:
          • Romil Singh, MD
        • Sub-Investigator:
          • Seung Jeong, MD
        • Sub-Investigator:
          • Andrew Ku, MD
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Wellspan Health
        • Contact:
        • Principal Investigator:
          • Muhammad Niazi, MD
        • Sub-Investigator:
          • Grant Sorkin, MD
        • Sub-Investigator:
          • Nicholas Caffes, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Ghada Mohamed, MD
        • Sub-Investigator:
          • Sami Al Kasab, MD
        • Sub-Investigator:
          • Kimberly Kicielinski, MD
        • Sub-Investigator:
          • Timothy Webb, MD
        • Sub-Investigator:
          • Orgest Lajthia, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Semmes-Murphey Foundation
        • Sub-Investigator:
          • Nitin Goyal, MD
        • Contact:
        • Principal Investigator:
          • Lucas Elijovich, MD
        • Sub-Investigator:
          • Violiza Inoa, MD
        • Sub-Investigator:
          • Adam S Arthur, MD, MPH
        • Sub-Investigator:
          • Daniel A Hoit, MD, MPH
        • Sub-Investigator:
          • Nickalus R. Khan, MD
        • Sub-Investigator:
          • Christopher M. Nickele, MD
        • Sub-Investigator:
          • Haydn A. Hoffman, MD
        • Sub-Investigator:
          • Nicolas K. Khattar, MD
    • Texas
      • Edinburg, Texas, United States, 78539
        • Not yet recruiting
        • DHR Health Institute for Research and Development
        • Principal Investigator:
          • Patricia Fernandez, MD
        • Contact:
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Houston Kingwood
        • Principal Investigator:
          • Mohamad Ezzeldin, MD
        • Contact:
        • Sub-Investigator:
          • Varun P Chaubal, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Ramesh Grandhi, MD, MS
        • Contact:
        • Sub-Investigator:
          • Robert Rennert, MD
        • Sub-Investigator:
          • Craig Kilburg, MD
        • Sub-Investigator:
          • Karol Budohoski, MD
    • Washington
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Ali Sultan-Qurraie, MD
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington
        • Principal Investigator:
          • Michael Levitt, MD
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia Univeristy
        • Contact:
        • 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 Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 90 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Health Ohio

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

March 8, 2026

Study Completion (Estimated)

May 8, 2027

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0525052522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All shared data will be aggregate.

Drug and device information, study documents

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

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