Evaluating the Safety and Efficacy of the Maurora® DES in ICAS (NCT05719883) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Safety and Efficacy of the Maurora® DES in ICAS
China156 participantsStarted 2023-02-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
What they're measuring
1
In-stent restenosis rate(ISR) within 12 months after procedure