Actively Recruiting
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
Led by ProMedica Health System · Updated on 2026-05-22
342
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adding endovascular adjunct stenting to mechanical thrombectomy (MT) for patients who have a large vessel occlusion stroke with significant residual narrowing (70-99%) in the brain arteries after clot removal attempts. This Phase 3 study focuses on patients with acute ischemic stroke caused by blockages in major brain arteries such as the internal carotid artery or middle cerebral artery. Patients eligible are adults aged 18 to 80 years who present with stroke symptoms and meet specific imaging and clinical criteria. Participants are randomly assigned to one of two groups: one group receives mechanical thrombectomy plus adjunct stenting, and the other group receives mechanical thrombectomy alone. The study uses devices such as aspiration catheters or stent retrievers for clot removal, followed by stenting if needed. Treatments are provided according to device instructions and labeling, with attention to timing within 24 hours of stroke onset. Some patients may also receive thrombolytic therapy if indicated and per standard guidelines. Throughout the study, participants will be monitored for safety and efficacy outcomes at multiple time points, including 90 days and one year post-treatment. Researchers will assess measures such as stroke severity scores, imaging results, and overall safety endpoints. Participants will undergo evaluations including neurological assessments and imaging scans, with close safety monitoring during and after the procedures. The study aims to understand how adjunct stenting may impact recovery and complications following mechanical thrombectomy in stroke patients.
CONDITIONS
Brief Title
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Symptoms consistent with acute ischemic stroke
- Imaging showing anterior occlusion of Internal Carotid Artery or Middle Cerebral Artery (MCA M1 or proximal M2) with residual 70-99% stenosis after clot retrieval
- NIH Stroke Scale score of 6 or higher
- Ability to randomize within 24 hours of stroke onset
- Pre-stroke modified Rankin Scale score of 0 to 2
- Signed informed consent obtained
- ASPECTS score of 6 or higher by non-contrast CT scan
- Score-ICAD score of 11 points or higher at screening or persistent stenosis of 70% or more after mechanical thrombectomy
- If eligible, thrombolytic therapy initiated per usual care and guidelines
- For those presenting more than 6 hours after stroke onset, infarct core volume less than 50 cc by CT perfusion
You will not qualify if you...
- Female participants who are pregnant or of child-bearing potential with positive pregnancy test
- Severe allergy to contrast media not controlled by medication
- CT evidence of midline shift, herniation, intracranial hemorrhage, or mass effect with ventricular effacement
- Acute bilateral strokes
- Contraindications to antiplatelet drugs or contrast agents
- Intracranial tumors other than small meningioma not requiring surgery for at least one year
- Known bleeding disorders, coagulation factor deficiencies, or anticoagulant therapy with high INR or PTT
- Baseline platelet count below 80,000 per microliter
- Life expectancy less than one year before stroke onset
- Participation in another randomized clinical trial that may affect outcomes
- Any condition posing significant risk for endovascular procedures as judged by investigator
- New or history of atrial fibrillation
- Suspected device-induced vasospasm
- Vessel dissection with specific vessel abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 24 hours of stroke onset
Participants receive mechanical thrombectomy with or without adjunct stenting as part of the intervention.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes after treatment.
Follow-up visits at immediate post treatment, 8 days or discharge, 90 days, and 1 year post treatment
Trial Site Locations
Total: 1 location
1
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
Research Team
S
Sami Al Kasab, MD
M
Mouhammad Jumaa, MD
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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