RECRUITING Phase 3 ClinicalTrials.gov

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Sponsor: Mercy Health Ohio • ClinicalTrials.gov ID: NCT05611242

Registry updated: 2026-10-02

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Description

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).

Interventions

MT+CAS with IV-AP (Procedure)
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 (Procedure)
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 (Procedure)
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

Eligibility criteria

Inclusion Criteria: 1. 18 to 79 years of age (before the 80th birthday) 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: 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test 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)

Conditions

Acute Ischemic Stroke

Locations

Mobile Infirmary Medical Center — Mobile, Alabama, United States
Adventist health — 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
Sarasota Memorial Hospital — Sarasota, 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
Northwestern University — 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
University of Louisville — Louisville, 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
Univerisity of New Mexico — Albuquerque, New Mexico, 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
Montefiore Medical Center — The Bronx, New York, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Cleveland Clinic Akron — Akron, Ohio, United States
University Hospitals — Cleveland, Ohio, 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
Brown University — Providence, Rhode Island, 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
Covenant Medical Center — Lubbock, 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

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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