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

Last updated: December 2, 2024
Sponsor: Mercy Health Ohio
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Thrombosis

Cerebral Ischemia

Treatment

Balloon Angioplasty

PO-Antiplatelet Drugs

MT+CAT with PO-AP

Clinical Study ID

NCT05611242
0525052522
  • Ages 18-79
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 M2segment AND extra-cranial proximal carotid occlusion / severe stenosis related toatherosclerosis 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 strokeonset 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 therapystarting between >6h to 16 hours from stroke onset, given the need for antiplatelettherapy.

  9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or withoutintracranial vascular occlusion

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

Exclusion

Exclusion Criteria:

  1. Females who are pregnant, or those of child-bearing potential with positive urine orserum beta Human Chorionic Gonadotropin (HCG) test

  2. Known severe allergy (more than a rash) to contrast media uncontrolled bymedications

  3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg ordiastolic 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

  1. Acute bilateral strokes

  2. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), orthrombolytic therapy, or contrast agents.

  3. Intracranial tumors other than small meningioma that does not require surgery forone year post randomization

  4. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulanttherapy with an International Normalized Ratio (INR) of >1.7 or PartialThromboplastin Time (PTT) > 3 times of normal

  5. Baseline platelet count <100,000 per microliter (μl)

  6. Life expectancy less than one year prior to stroke onset

  7. Participation in another randomized clinical trial that could confound theevaluation of the study outcomes

  8. Any other condition (in the opinion of the site investigator) that precludes anendovascular procedure or poses a significant hazard to the patient if anendovascular procedure was performed

  9. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu'sArteritis)

Study Design

Total Participants: 404
Treatment Group(s): 8
Primary Treatment: Balloon Angioplasty
Phase: 3
Study Start date:
May 08, 2024
Estimated Completion Date:
May 08, 2027

Study 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

Connect with a study center

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36607
    United States

    Active - Recruiting

  • Pomona Valley

    Pomona, California 91767
    United States

    Active - Recruiting

  • Sutter Institute for Medical Research

    Sacramento, California 95816
    United States

    Site Not Available

  • California Pacific Medical Center/Mils Peninsula Medical Center

    San Francisco, California 94107
    United States

    Active - Recruiting

  • Baptist Health South Florida

    Coral Gables, Florida 33143
    United States

    Active - Recruiting

  • Delray Medical Center

    Delray Beach, Florida 33484
    United States

    Active - Recruiting

  • Orlando Health, Inc.

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • WellStar Health System, Inc

    Marietta, Georgia 30062
    United States

    Active - Recruiting

  • Ascension/Alexian Brothers Health System

    Chicago, Illinois 60606
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Munster Community Hospital

    Munster, Indiana 46321
    United States

    Active - Recruiting

  • Baptist Healthcare Systems, Inc

    Lexington, Kentucky 40299
    United States

    Active - Recruiting

  • Louisiana State University Health Sciences Center at Shreveport

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • University of Massachusetts

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • McLaren Flint

    Flint, Michigan 48532
    United States

    Active - Recruiting

  • Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan 49007
    United States

    Active - Recruiting

  • Michigan State University

    Lansing, Michigan 48912
    United States

    Active - Recruiting

  • University of Michigan Health Sparrow

    Lansing, Michigan 48912
    United States

    Active - Recruiting

  • McLaren Macomb

    Mount Clemens, Michigan 48043
    United States

    Active - Recruiting

  • SSM Health DePaul Hospital

    Saint Louis, Missouri 63044
    United States

    Active - Recruiting

  • Rutgers, The State University

    Piscataway, New Jersey 08854
    United States

    Active - Recruiting

  • Albany Medical College

    Albany, New York 12208
    United States

    Active - Recruiting

  • Northwell Health- South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Active - Recruiting

  • WellSpan Health

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Semmes-Murphey Foundation

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • DHR Health Institute for Research and Development

    Edinburg, Texas 78539
    United States

    Site Not Available

  • HCA Houston Kingwood

    Houston, Texas 77004
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Valley Medical Center

    Renton, Washington 98055
    United States

    Active - Recruiting

  • West Virginia Univeristy

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.