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NCT05611242PHASE3Recruiting

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

Mercy Health Ohio

Start Date

5/8/2024

Completion Date

5/8/2027

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).

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

Eligibility Criteria

Age Range: 18 years to 79 years

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)

Interventions

PROCEDURE

MT+CAS with IV-AP

PROCEDURE

MT+CAS with PO-AP

PROCEDURE

MT+CAT with PO-AP

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Conditions

Acute Ischemic Stroke

Locations

Mobile Infirmary Medical Center

Mobile, Alabama 36607

United States

Glendale Adventist Medical Center

Glendale, California 91206

United States

University of California, Irvine

Irvine, California 92697

United States

Pomona Valley

Pomona, California 91767

United States

Sutter Institute for Medical Research

Sacramento, California 95816

United States

California Pacific Medical Center/Mils Peninsula Medical Center

San Francisco, California 94107

United States

Boca Raton - Baptist Health

Boca Raton, Florida 33486

United States

Delray Medical Center

Delray Beach, Florida 33484

United States

Baptist Health Research Institute

Jacksonville, Florida 32207

United States

University of Florida Health Jacksonville

Jacksonville, Florida 32209

United States

University of Miami School of Medicine

Miami, Florida 33136

United States

Orlando Health, Inc.

Orlando, Florida 32806

United States

University of South Florida

Tampa, Florida 33606

United States

St. Mary's Medical Center

West Palm Beach, Florida 33407

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

WellStar Health System, Inc

Marietta, Georgia 30062

United States

Ascension/Alexian Brothers Health System

Chicago, Illinois 60606

United States

University of Chicago

Chicago, Illinois 60637

United States

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois 60190

United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana 46202

United States

Munster Community Hospital

Munster, Indiana 46321

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Baptist Healthcare Systems, Inc

Lexington, Kentucky 40299

United States

Ochsner Medical Center

New Orleans, Louisiana 70121

United States

Louisiana State University Health Sciences Center at Shreveport

Shreveport, Louisiana 71103

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

University of Massachusetts

Worcester, Massachusetts 01655

United States

McLaren Flint

Flint, Michigan 48532

United States

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

Kalamazoo, Michigan 49007

United States

Michigan State University

Lansing, Michigan 48912

United States

McLaren Macomb

Mount Clemens, Michigan 48043

United States

SSM Health DePaul Hospital

St Louis, Missouri 63044

United States

JFK University Medical Center

Edison, New Jersey 08837

United States

Rutgers, The State University

Piscataway, New Jersey 08854

United States

Albany Medical College

Albany, New York 12208

United States

Northwell Health- South Shore University Hospital

Bay Shore, New York 11706

United States

Mount Sinai Hospital

New York, New York 10029

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio 43608

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania 15212

United States

WellSpan Health

York, Pennsylvania 17403

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Semmes-Murphey Foundation

Memphis, Tennessee 38120

United States

DHR Health Institute for Research and Development

Edinburg, Texas 78539

United States

HCA Houston Kingwood

Houston, Texas 77004

United States

University of Utah

Salt Lake City, Utah 84112

United States

Valley Medical Center

Renton, Washington 98055

United States

University of Washington

Seattle, Washington 98195

United States

West Virginia Univeristy

Morgantown, West Virginia 26506

United States