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.
研究组 & 干预措施
Test group
Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use pEGASUS stent system assisted to treat intracranial aneurysm.
干预措施: pEGASUS Stent System (Device)
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)