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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- In-stent restenosis rate(ISR) within 12 months after procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents;
- •Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit);
- •Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;
- •Life expectancy <12 months;
- •Pregnant or lactating women, or planning for pregnancy;
- •Participated in another investigational device or drug study within 30 days;
- •According to the judgement of the investigator, other situations that are not suitable for enrollment.
研究组 & 干预措施
Maurora® Sirolimus Eluting Stent System
Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.
干预措施: Maurora® Sirolimus Eluting Stent System (Device)
APOLLO™ Intracranial Stent System
Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.
干预措施: APOLLO™ Intracranial Stent System (Device)
结局指标
主要结局
In-stent restenosis rate(ISR) within 12 months after procedure
时间窗: 12 months after procedure
Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure
次要结局
- 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)