A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 42
- 主要终点
- Neurological death or disabling stroke
研究概览
简要总结
A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject age is ≥ 18 and ≤80 years
- •Subject is eligible for Surpass Evolve FDS IFU, and/or physician intends to treat the subject with Surpass Evolve FDS per his/her judgement
- •Subject, or subject's legally authorised representative (LAR) has provided signed informed consent using the Ethics Committee (EC)-approved consent form
- •Subject is willing to comply with scheduled visits and examinations per institutional SOC
排除标准
- •Subject has any non-target intracranial aneurysm treated within 30 days prior to study enrollment
- •Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study within 12 months post procedure
- •Subject has undergone previous treatment where it would interfere with the delivery and/ or placement and/or proper apposition of Surpass Evolve FDS
- •Subject has acute target aneurysm rupture and/or subarachnoid hemorrhage occurred within 30 days prior to enrollment
- •Subject has any condition demonstrated as Warning or Precautions in IFU
- •Antiplatelet and/or anticoagulation therapy (e.g. aspirin and clopidogrel) is contraindicated for the subject
- •Subject has not received dual anti-platelet agents prior to the procedure
- •Subject with an active bacterial infection
- •Subject in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
- •Severe intracranial vessel tortuosity or stenosis; and/or
- •Intracranial vasospasm not responsive to medical therapy
- •Female subjects who are pregnant/ nursing, or who are unwilling or unable to take adequate method of contraception prior to the 12-month study follow-up.*
- •*If the subject becomes pregnant during her participation, the physician will have to evaluate the risk associated to her continuing participation to the rest of the study.
- •Enrollment in another trial involving an investigational product and/or drug interfere with study procedure/ results
- •The investigator determined that the health of the patient may be compromised by the patient's enrollment
结局指标
主要结局
Neurological death or disabling stroke
时间窗: 12 months (-3/ +6 months) post-procedure
Neurological death or disabling stroke at 12 months post-procedure (-3/ + 6 months). * Neurological death defined as stroke-related death * Disabling stroke defined as stroke in the treated vascular territory that results in a mRS score ≥ 3, assessed by a qualified investigator at a minimum 90-days post stroke event
100% occlusion without significant parent artery stenosis
时间窗: 12 months (-3/+6 months) post-procedure
A composite of 100% occlusion (defined as Raymond-Roy class 1) of the target aneurysm without significant parent artery stenosis (significant stenosis defined as ˃50% stenosis), per the assessment of images required, and with no retreatment of target aneurysm at 12 months (-3/+6 months) post-procedure.
次要结局
- Procedure- and device-related serious adverse events(60 months)
- Procedural success(Intraprocedural)
- Key neurological events(60 months)
- Device success(Intraprocedural)
- Re-sheathing success(Intraprocedural)