Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Rate of major ipsilateral stroke or neurological death
研究概览
简要总结
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
详细描述
Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 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 wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neck width≥4mm or bodyor a dome-to-neck ratio<2);
- •Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;
- •Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;
- •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.
- •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.
- •Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma.
- •The target aneurysm has previously received intravascular embolization or stent implantation treatment;
- •Multiple aneurysms or complex aneurysms;
- •Patients with acute ruptured aneurysm;
- •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 major ipsilateral stroke or neurological death
时间窗: 12 months
Any major ipsilateral stroke or neurological death
Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography
时间窗: 6 months
Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.
次要结局
- Technical success rate(Within 24 hours after surgery)
- Rate of complete occlusion(Within 24 hours after surgery, 6 months, 12 months)
- Rate of successful occlusion(Within 24 hours after surgery, 6 months, 12 months)
- Death, stroke, and thrombotic events(to 12 months)
- Rate of good clinical prognosis(3 months, 6 months, 12 months)