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

NCT05719883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Intracranial Arteriosclerosis
  • Stroke (CVA) or TIA

Interventions

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.

Sponsors & Collaborators

  • Alain Medical (Beijing) Co., Ltd.

    collaborator UNKNOWN

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Ning Ma, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-04-30
Completion
2025-05-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719883 on ClinicalTrials.gov