Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
NCT ID: NCT05611242
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
404 participants
INTERVENTIONAL
2024-05-08
2027-05-08
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MT+CAT
Non-stenting group constitutes best medical management (BMM)+intra-arterial treatment (IAT) with mechanical thrombectomy (for IVO) added to extra-cranial proximal carotid occlusion angioplasty or aspiration (MT+CAT)
MT+CAT with PO-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy
MT+CAS
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). Within the stenting arm, there will be 2 different subgroups based on the antiplatelet treatment protocol per the site standard of care (oral antiplatelet or IV antiplatelet medication (e.g., Cangrelor or others).
MT+CAS with IV-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
MT+CAS with PO-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
Interventions
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MT+CAS with IV-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added intravenous antiplatelet therapy.
MT+CAS with PO-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy.
MT+CAT with PO-AP
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Carotid stenting is a procedure that is deployed within the lumen of the carotid artery which treats the narrowing of the carotid artery. With added oral antiplatelet therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
79 Years
ALL
No
Sponsors
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Mercy Health Ohio
OTHER
Responsible Party
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Dr. Osama O. Zaidat
Neuroscience and Stroke Medical Director
Principal Investigators
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Osama O Zaidat, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mercy Health St. Vincent Medical Center
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Glendale Adventist Medical Center
Glendale, California, United States
University of California, Irvine
Irvine, California, United States
Pomona Valley
Pomona, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
California Pacific Medical Center/Mils Peninsula Medical Center
San Francisco, California, United States
Boca Raton - Baptist Health
Boca Raton, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
St. Mary's Medical Center
West Palm Beach, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
WellStar Health System, Inc
Marietta, Georgia, United States
Ascension/Alexian Brothers Health System
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Munster Community Hospital
Munster, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Healthcare Systems, Inc
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
McLaren Flint
Flint, Michigan, United States
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, United States
Michigan State University
Lansing, Michigan, United States
McLaren Macomb
Mount Clemens, Michigan, United States
SSM Health DePaul Hospital
St Louis, Missouri, United States
JFK University Medical Center
Edison, New Jersey, United States
Rutgers, The State University
Piscataway, New Jersey, United States
Albany Medical College
Albany, New York, United States
Northwell Health- South Shore University Hospital
Bay Shore, New York, United States
Mount Sinai Hospital
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Semmes-Murphey Foundation
Memphis, Tennessee, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
HCA Houston Kingwood
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Valley Medical Center
Renton, Washington, United States
University of Washington
Seattle, Washington, United States
West Virginia Univeristy
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0525052522
Identifier Type: -
Identifier Source: org_study_id