Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
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
Interventions
MT+CAS with IV-AP
MT+CAS with PO-AP
MT+CAT with PO-AP
Conditions
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