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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. ;


Study Design


Related Conditions & MeSH terms


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

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