NCT05719883

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Arteriosclerosis
• Stroke (CVA) or TIA

Interventions

Type	Name	Description
DEVICE	Maurora® Sirolimus Eluting Stent System	The Maurora® for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
DEVICE	APOLLO™ Intracranial Stent System	The Apollo stent system comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-04-30
• Completion: 2025-05-15
• First posted: 2023-02-09
• Last updated: 2025-06-26

Locations

1 site across 1 country: China