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)

Beijing Tiantan Hospital1 site in 1 country156 target enrollmentFebruary 20, 2023

ConditionsIntracranial Arteriosclerosis Stroke (CVA) or TIA

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intracranial Arteriosclerosis
Sponsor: Beijing Tiantan Hospital
Enrollment: 156
Locations: 1
Primary Endpoint: In-stent restenosis rate(ISR) within 12 months after procedure
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

February 20, 2023

End Date

May 15, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Tiantan Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age from 18 to 80 years;
•Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack \[TIA\] associated with intracranial atherosclerosis within 90 days of enrollment);
•A major intracranial artery (carotid artery, MCA stem \[M1\], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method);
•The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter \>1.5mm;
•Only one stent planned for the target lesion;
•A Modified Rankin Score of ≤ 3;
•Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent.

Exclusion Criteria

•Ischemic stroke within 2 weeks before the procedure;
•Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;
•Patients with stroke caused by perforating artery occlusion;
•Severe calcification at target lesion;
•Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks;
•History of stenting or angioplasty of an intracranial artery;
•Intracranial tumor, aneurysm or intracranial arteriovenous malformation;
•Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization;
•Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation);
•Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure;

Outcomes

Primary Outcomes

In-stent restenosis rate(ISR) within 12 months after procedure

Time Frame: 12 months after procedure

Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure

Secondary Outcomes

Implantation success rate(During the procedure)
Ischemic stroke in other vessel territory between 31 day to 1 year after procedure(between 31 day to 1 year after procedure)
Any ischemic stroke between 31 day to 1 year after procedure(between 31 day to 1 year after procedure)
Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure(between 31 day to 1 year after procedure)
Functional outcome measured by the modified Rankin Scale(1 and 12 months after procedure)
Death between 31 day to 1 year after procedure(between 31 day to 1 year after procedure)
Technical success rate(During the procedure)
Stroke in the target vessel territory or death within 30 days after procedure(within 30 days after procedure)
Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure(between 31 day to 1 year after procedure)
Clinical success rate(12 months after procedure)
Stroke or death within 30 days after procedure(within 30 days after procedure)
Transient Ischemic Attack within 1 year after the procedure(1 year after the procedure)