Phase
Condition
Stroke
Thrombosis
Cerebral Ischemia
Treatment
Balloon Angioplasty
PO-Antiplatelet Drugs
MT+CAT with PO-AP
Clinical Study ID
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 to 79 years of age (before the 80th birthday)
Presenting with symptoms consistent with AIS
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%
NIHSS ≥ 4
Ability to randomize and start endovascular therapy within 16 hours of stroke onset
Pre-stroke mRS score 0-2
Ability to obtain signed informed consent
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.
Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or withoutintracranial vascular occlusion
Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
Exclusion
Exclusion Criteria:
Females who are pregnant, or those of child-bearing potential with positive urine orserum beta Human Chorionic Gonadotropin (HCG) test
Known severe allergy (more than a rash) to contrast media uncontrolled bymedications
Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg ordiastolic blood pressure >110 mmHg) despite medication
CT evidence of the following conditions:
Midline shift or herniation
Evidence of intracranial hemorrhage
Mass effect with effacement of the ventricles
Acute bilateral strokes
Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), orthrombolytic therapy, or contrast agents.
Intracranial tumors other than small meningioma that does not require surgery forone year post randomization
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
Baseline platelet count <100,000 per microliter (μl)
Life expectancy less than one year prior to stroke onset
Participation in another randomized clinical trial that could confound theevaluation of the study outcomes
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
Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu'sArteritis)
Study Design
Study Description
Connect with a study center
Mobile Infirmary Medical Center
Mobile, Alabama 36607
United StatesActive - Recruiting
Pomona Valley
Pomona, California 91767
United StatesActive - Recruiting
Sutter Institute for Medical Research
Sacramento, California 95816
United StatesSite Not Available
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California 94107
United StatesActive - Recruiting
Baptist Health South Florida
Coral Gables, Florida 33143
United StatesActive - Recruiting
Delray Medical Center
Delray Beach, Florida 33484
United StatesActive - Recruiting
Orlando Health, Inc.
Orlando, Florida 32806
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
WellStar Health System, Inc
Marietta, Georgia 30062
United StatesActive - Recruiting
Ascension/Alexian Brothers Health System
Chicago, Illinois 60606
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Munster Community Hospital
Munster, Indiana 46321
United StatesActive - Recruiting
Baptist Healthcare Systems, Inc
Lexington, Kentucky 40299
United StatesActive - Recruiting
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
University of Massachusetts
Worcester, Massachusetts 01655
United StatesActive - Recruiting
McLaren Flint
Flint, Michigan 48532
United StatesActive - Recruiting
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan 49007
United StatesActive - Recruiting
Michigan State University
Lansing, Michigan 48912
United StatesActive - Recruiting
University of Michigan Health Sparrow
Lansing, Michigan 48912
United StatesActive - Recruiting
McLaren Macomb
Mount Clemens, Michigan 48043
United StatesActive - Recruiting
SSM Health DePaul Hospital
Saint Louis, Missouri 63044
United StatesActive - Recruiting
Rutgers, The State University
Piscataway, New Jersey 08854
United StatesActive - Recruiting
Albany Medical College
Albany, New York 12208
United StatesActive - Recruiting
Northwell Health- South Shore University Hospital
Bay Shore, New York 11706
United StatesActive - Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Mercy Health St. Vincent Medical Center
Toledo, Ohio 43608
United StatesActive - Recruiting
WellSpan Health
York, Pennsylvania 17403
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Semmes-Murphey Foundation
Memphis, Tennessee 38120
United StatesActive - Recruiting
DHR Health Institute for Research and Development
Edinburg, Texas 78539
United StatesSite Not Available
HCA Houston Kingwood
Houston, Texas 77004
United StatesActive - Recruiting
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Valley Medical Center
Renton, Washington 98055
United StatesActive - Recruiting
West Virginia Univeristy
Morgantown, West Virginia 26506
United StatesActive - Recruiting
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