NCT06140550尚未招募不适用
Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis
Bochang0 个研究点目标入组 204 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 主要终点
- 6-month target lesion restenosis rate
研究概览
简要总结
This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.
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
- •18 to 80 years old;
- •Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70~99%(WASID method);
排除标准
- •Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
- •Ischemic cerebral infarction occurred 3 weeks before surgery;
- •Cerebral hemorrhage 3 months before operation;
结局指标
主要结局
6-month target lesion restenosis rate
时间窗: 6-month
次要结局
未报告次要终点
研究者
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