Actively Recruiting
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Led by Mercy Health Ohio · Updated on 2025-12-17
404
Participants Needed
51
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 79 years (before 80th birthday)
- Presenting with symptoms consistent with acute ischemic stroke
- Imaging shows anterior circulation occlusion of internal carotid artery terminus, middle cerebral artery main stem (MCA M1), or proximal M2 segment
- Extra-cranial proximal carotid occlusion or severe narrowing (≥70%) related to atherosclerosis on non-invasive imaging
- National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher
- Able to start endovascular therapy within 16 hours of stroke onset
- Pre-stroke modified Rankin Scale (mRS) score of 0 to 2
- Able to provide signed informed consent
- ASPECTS score of 7 or higher on non-contrast CT or MRI (DWI) if within 6 hours of stroke onset, or ASPECTS ≥7 plus infarct core volume less than 50 cc on CT perfusion or less than 25 cc on MRI-DWI for therapy starting between over 6 to 16 hours from onset
- Acute neurological deficit with imaging evidence of tandem lesion: extracranial carotid occlusion (70% to 100%) with or without intracranial vascular occlusion
- Ineligible for or failed intravenous tissue plasminogen activator (IV t-PA) therapy
You will not qualify if you...
- Pregnant females or females of child-bearing potential with positive pregnancy test
- Severe allergy to contrast media not controlled by medications
- Refractory hypertension with systolic blood pressure over 185 mmHg or diastolic over 110 mmHg despite medication
- CT evidence of midline shift or herniation, intracranial hemorrhage, or mass effect with ventricle effacement
- Acute bilateral strokes
- Contraindication to antiplatelet or thrombolytic therapy or contrast agents
- Intracranial tumors other than small meningioma not requiring surgery for one year post-randomization
- Known bleeding disorders, coagulation factor deficiency, or on anticoagulants with INR >1.7 or PTT > 3 times normal
- Baseline platelet count less than 100,000 per microliter
- Life expectancy less than one year before stroke onset
- Participation in another randomized clinical trial that could interfere with outcomes
- Any condition that makes endovascular procedures unsafe or risky as judged by the site investigator
- Proximal carotid stenosis caused by dissection or vasculitis such as Takayasu's arteritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Actively Recruiting
3
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
4
Pomona Valley
Pomona, California, United States, 91767
Actively Recruiting
5
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Not Yet Recruiting
6
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California, United States, 94107
Actively Recruiting
7
Boca Raton - Baptist Health
Boca Raton, Florida, United States, 33486
Actively Recruiting
8
Delray Medical Center
Delray Beach, Florida, United States, 33484
Actively Recruiting
9
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
10
University of Florida Health Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
11
University of Miami School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
12
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
13
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
14
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Actively Recruiting
15
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
16
WellStar Health System, Inc
Marietta, Georgia, United States, 30062
Actively Recruiting
17
Ascension/Alexian Brothers Health System
Chicago, Illinois, United States, 60606
Actively Recruiting
18
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
19
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States, 60190
Actively Recruiting
20
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
21
Munster Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
22
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
23
Baptist Healthcare Systems, Inc
Lexington, Kentucky, United States, 40299
Actively Recruiting
24
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
25
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana, United States, 71103
Actively Recruiting
26
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
27
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
28
McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
29
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
30
Michigan State University
Lansing, Michigan, United States, 48912
Actively Recruiting
31
McLaren Macomb
Mount Clemens, Michigan, United States, 48043
Actively Recruiting
32
SSM Health DePaul Hospital
St Louis, Missouri, United States, 63044
Actively Recruiting
33
JFK University Medical Center
Edison, New Jersey, United States, 08837
Actively Recruiting
34
Rutgers, The State University
Piscataway, New Jersey, United States, 08854
Actively Recruiting
35
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
36
Northwell Health- South Shore University Hospital
Bay Shore, New York, United States, 11706
Actively Recruiting
37
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
38
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
39
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
40
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Actively Recruiting
41
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
42
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
43
WellSpan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
44
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
45
Semmes-Murphey Foundation
Memphis, Tennessee, United States, 38120
Actively Recruiting
46
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
Not Yet Recruiting
47
HCA Houston Kingwood
Houston, Texas, United States, 77004
Actively Recruiting
48
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
49
Valley Medical Center
Renton, Washington, United States, 98055
Actively Recruiting
50
University of Washington
Seattle, Washington, United States, 98195
Not Yet Recruiting
51
West Virginia Univeristy
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
J
Jasmine M Olvany, PhD
CONTACT
L
Laila Ibrahim, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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