Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window — RESILIENTExt  

Stroke, Ischemic Clinical Trial

Official title: Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial in the Extended Time Window

Status Recruiting

Clinical Trial Summary

A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well

Clinical Trial Description

Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (≤68 vs. >68 years), baseline NIHSS (<17 v. ≥17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators. ;

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

• NCT number: NCT04256096
• Study type: Interventional
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Sheila CO Martins, MD, PhD
• Phone: 51999628467
• Email: scmartins@hcpa.edu.br
• Status: Recruiting
• Phase: Phase 3
• Start date: March 9, 2020
• Completion date: May 1, 2022