Stroke Research & Data

Primary Investigator: Sushrut Dharmadhikari M.D.

National Clinical Trials Identifier: NCT03805308

Clinical Trial Link

Enrollment Status: Open

Clinical Trial Summary:

Phase III

Funding Agency/Sponsor: Mercy Health Ohio, Genentech, Cerenovus, Medtronic, Penumbra, Stryker

Disease: Ischemic Stroke

Enrollment/Eligibility

Inclusion Criteria:

1. 18 to 85 years of age
2. Presenting with symptoms consistent with an acute ischemic stroke
3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
4. NIHSS score >6 at the time of randomization
5. Ability to randomize within 24 hours of stroke onset
6. Pre-stroke mRS score 0-1
7. Ability to obtain signed informed consent

Imaging evidence of moderate-large infarct defined as:

1. NCCT ASPECTS 2-5

Exclusion Criteria:

• 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)
• CT evidence of the following conditions:
  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
• Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
• Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
• Rapidly improving neurological status prior to randomization to NIHSS <6
• Bilateral strokes or multiple intracranial occlusions
• Intracranial tumors
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
• Baseline platelet count <30,000 per microliter (µl)
• Life expectancy less than 90 days prior to stroke onset
• Participation in another randomized clinical trial that could confound the evaluation of the study
• 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