Evaluating the Safety and Efficacy of the Maurora® DES in ICAS — Maurora ICAS  

Stroke (CVA) or TIA Clinical Trial

Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the Maurora® Sirolimus-Eluting Stent Versus the Apollo Stent in Intracranial Atherosclerotic Stenosis(Maurora ICAS Trial)

Status Recruiting

Clinical Trial Summary

The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) is more efficacious than bare metal stent (BMS) in prevention of in-stent restenosis (ISR) and improvement of outcomes for symptomatic intracranial atherosclerotic stenosis. This trial is prospective, multi-center, randomized 1:1 single blind trial using Maurora sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 10 interventional neurology centers in China. The study is sponsored by Alain Medical (Beijing) Co., Ltd.

Clinical Trial Description

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent versus bare metal stent (BMS) to treat intracranial stenosis of 70-99% degree. The primary endpoint is in-stent restenosis rate(ISR) within 12 months after revascularization procedure of the qualifying lesion during follow-up. ;

Related Conditions & MeSH terms

• Arteriosclerosis
• Intracranial Arteriosclerosis
• Stroke (CVA) or TIA

• NCT number: NCT05719883
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Contact: Baixue Jia, MD
• Phone: 15010125093
• Email: beckyberry@163.com
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Completion date: May 2025