NCT06158750招募中不适用
A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of complete occlusion
研究概览
简要总结
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
详细描述
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged from 18 to 80 years, male or female;
- •Patients diagnosed as intracranial aneurysms by brain CTA/MRA/DSA;
- •Patients with unruptured saccular aneurysms or fusiform aneurysm who are clinically determined to use flow modulation device for endovascular treatment;
- •The diameter of the target aneurysm parent vessel was 1.75-5mm;
- •Patients target aneurysm is planned to be embolized using flow modulation devices only;
- •The mRS Score of the patients was 0-2
- •Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.
排除标准
- •Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment;
- •Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography;
- •Patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery;
- •Patients with target aneurysm treated with endovascular interventional therapy before enrollment;
- •Known to be allergic to Nitinol platinum alloy and angiographic agents;
- •Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation;
- •The target aneurysms were blood vesicular aneurysms, pseudoaneurysms, or aneurysms associated with arteriovenous malformation, moyamoya disease, or multiple aneurysms that could not be treated by a single flow modulation device;
- •Serious infection is not controlled and is not suitable for operation;
- •Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;
- •Obvious abnormal coagulation function or bleeding tendency;
- •Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;
- •Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;
- •Participation in any other clinical trial within 30 days prior to signing informed consent;
- •Other conditions considered by the investigator to be inappropriate for enrollment.
结局指标
主要结局
Rate of complete occlusion
时间窗: 12 months
Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.
次要结局
- Technical success rate(Within 24 hours after surgery)
- Rate of complete occlusion(6 months)
- Rate of successful occlusion(6 months, 12 months)
- Rate of good clinical prognosis(3 months, 6 months, 12 months)
- Rate of in-stent-stenosis(to 6 months, to 12 months)
- Device performance evaluation(Within 24 hours after surgery)
- Death, stroke, and thrombotic events(to 12 months)
研究者
研究点 (1)
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