Study of Mechanical Thrombectomy With or Without Adjunct Stenting for Treating Acute Ischemic Stroke Due to Large Vessel Blockage and Severe Intracranial Narrowing

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.

Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis