Observational Study of Rescue Stenting Using CREDO Heal Stent After Unsuccessful Mechanical Thrombectomy in Adults With Acute Stroke Due to Intracranial Artery Narrowing

What this Trial Is About

This research aims to assess the effectiveness and safety of permanently placing a self-expandable CREDO4 heal Stent in patients with symptomatic intracranial artery narrowing, following unsuccessful attempts to reopen blocked large blood vessels in the brain caused by acute ischemic stroke. The study focuses on cases where mechanical thrombectomy has failed to restore blood flow, targeting arteries in either the front or back circulation of the brain. Participants will receive rescue stenting using the CREDO4 heal Stent combined with the NeuroSpeed PTA Balloon Catheter after at least one unsuccessful mechanical recanalization attempt with devices such as stent retrievers or aspiration. Treatment is intended for patients with suitable intracranial artery stenosis and symptoms starting less than 24 hours before the procedure. The stenting procedure is performed according to specific instructions for use and physician assessment. During the study, researchers will evaluate technical success by the proportion of patients achieving good blood flow eTICI 2b-3 immediately after treatment and clinical success by the proportion of patients with good functional outcome mRS 0-2 at about 90 days post-procedure. Participants will be monitored for stroke symptom changes and disability levels, with assessments at the procedures end and follow-up visits to measure recovery and safety over time.

REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)