Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
- Conditions
- Acute Ischemic Stroke
- Interventions
- Procedure: MT+CAT with PO-APProcedure: MT+CAS with IV-APProcedure: MT+CAS with PO-AP
- Registration Number
- NCT05611242
- Lead Sponsor
- Mercy Health Ohio
- Brief 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 404
-
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 M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis 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 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.
-
Acute Neurological Deficit with Imaging evidence of Tandem Lesion:
Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
-
Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy
-
Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
-
Known severe allergy (more than a rash) to contrast media uncontrolled by medications
-
Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic 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), or thrombolytic therapy, or contrast agents.
-
Intracranial tumors other than small meningioma that does not require surgery for one year post randomization
-
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
-
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 the evaluation of the study outcomes
-
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
-
Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT+CAT MT+CAT with PO-AP 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+CAS MT+CAS with IV-AP 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 MT+CAS with PO-AP 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).
- Primary Outcome Measures
Name Time Method 90-day Modified Rankin Scale ordinal shift Time Frame: 90 days post randomization Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death.
0 = No symptoms at all.
1. No significant disability despite symptoms; able to carry out all usual duties and activities.
2. Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
3. Moderate disability requiring some help, but able to walk without assistance.
4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
6. Death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
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
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
Ascension/Alexian Brothers Health System
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, 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
Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine
🇺🇸Kalamazoo, Michigan, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
WellSpan Health
🇺🇸York, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
DHR Health Institute for Research and Development
🇺🇸Edinburg, Texas, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Baptist Health South Florida
🇺🇸Coral Gables, Florida, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
WellStar Health System, Inc
🇺🇸Marietta, Georgia, United States
Munster Community Hospital
🇺🇸Munster, Indiana, United States
Baptist Healthcare Systems, Inc
🇺🇸Lexington, Kentucky, United States
McLaren Flint
🇺🇸Flint, Michigan, United States
McLaren Macomb
🇺🇸Mount Clemens, Michigan, United States
SSM Health DePaul Hospital
🇺🇸Saint Louis, Missouri, 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
Mercy Health St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Semmes-Murphey Foundation
🇺🇸Memphis, Tennessee, 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
West Virginia Univeristy
🇺🇸Morgantown, West Virginia, United States