Trenza Embolization Device for Intrasaccular Aneurysm Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- Safety primary outcome measure
研究概览
简要总结
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
详细描述
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
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
- •Age is ≥18 and ≤80 years
- •Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment (Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days).
- •Aneurysm morphology is saccular
- •Aneurysm size is between 6-12 mm
- •Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm
- •If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt & Hess Score of 1 or
- •Must be willing to comply with protocol required procedures and follow up
- •Must be willing to sign and date an Ethics Committee approved written informed consent prior to initiation of any screening or study procedures
- •Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures
排除标准
- •Target aneurysm has been previously treated.
- •Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm.
- •Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm.
- •Treatment with flow diverting stent implant is anticipated.
- •A planned, staged procedure is anticipated.
- •Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery.
- •Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage.
- •Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable)
- •Has a known coagulopathy or is on chronic anticoagulant therapy.
- •Is pregnant or intends to become pregnant during the study or is breastfeeding.
- •Is concurrently involved in another study that could affect outcomes of IA treatment.
- •Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years.
- •Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure.
- •Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.
结局指标
主要结局
Safety primary outcome measure
时间窗: 1 year (± 6 months)
The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Effectiveness primary outcome measure
时间窗: 1 year (± 6 months)
The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (\>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met: * 100% occlusion (Raymond Class I) demonstrated by angiographic measurement at 12 months (+6/-3 months) post-procedure, or * Stable Raymond Class II demonstrated on 2 serial angiographic measurements obtained a minimum of 6 months (± 1 month) apart
次要结局
- Safety secondary outcome measure(1 year (± 6 months))