NCT06683118Enrolling By Invitation不适用
A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS
MicroPort NeuroTech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2024年5月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Target lesion restenosis rate at 6 month postoperative
研究概览
简要总结
The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis
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
- None
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
- •Incsion Criteria:
- •Age 18 to 80 years old at informed consent signing.
- •Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis.
- •Medication ineffective.
- •modified Rankin Scale(mRS) score≤
- •The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.
排除标准
- •History of acute ischemic stroke within 2 weeks;
- •Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
- •Target vessels complete occlusion or with thrombus in target vessels;
- •Target vessel with severe calcification or distortion that making interventional device is difficult to place;
- •History of stenting in the target artery;
- •Target vessel restenosis following stenting or balloon angioplasty;
- •Combined with other lesion with ≥70% stenosis in target vessel.
- •Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
- •Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
- •History of intracranial hemorrhage within 90days.
- •Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
- •Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
- •Allergic to contrast agents or rapamycin;
- •Pregnant or lactating women;
- •Participating or intending to participate in any other drug/device clinical trials;
- •Life expectancy <1 year;
- •Any other conditions that the investigator deems the patient unsuitable for enrollment.
研究组 & 干预措施
control group
Active Comparator
干预措施: Conventional Balloon (Device)
experimental group
Experimental
干预措施: Rapamycin neurovascular Balloon Catheter (Device)
结局指标
主要结局
Target lesion restenosis rate at 6 month postoperative
时间窗: 180±30days
The primary endpoint was the restenosis rate at 6 month postoperatively. Restenosis was defined as ≥50% measured stenosis of the target lesion by imaging according to WASID method.
次要结局
- Technical succeed rate(Intraoperation)
- Any stroke or death at 30 days postoperatively(30±7days)
- Target vascular-related stroke or death at 12 month postoperatively(360±60days)
- Any stroke or death at 12 month postoperatively(360±60days)
- Target vascular-related stroke or death at 30 days postoperatively(30±7days)
- Target vascular-related stroke or death at 6 month postoperatively(180±30days)
- Any stroke or death at 6 month postoperatively(180±30days)
研究者
研究点 (2)
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