NCT04999423进行中（未招募）不适用
Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment
Microvention-Terumo, Inc.19 个研究点 分布在 5 个国家目标入组 206 人开始时间: 2022年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
- 试验地点
- 19
- 主要终点
- Proportion of aneurysms with complete occlusion
研究概览
简要总结
This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure
详细描述
Patient treatment and follow-up will be performed as per standard of care. The study will evaluate the proportion of aneurysms with complete occlusion based on Raymond-Roy occlusion classification (RROC) at 12 ± 6-months, as well as other effectiveness and safety endpoints such as the occurence of stent stenosis or parent artery occlusion, the occurence of retreatment and recanalization, the rate of major ipsilateral stroke or neurological death, the proportion of patients with good functional clinical outcome, the occurence of SAH, aneurysm rupture, procedural complications, serious adverse events...
Sample size: 200 patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient whose age is 18 years old or above;
- •Patient (or legal representative, where applicable) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed;
- •Patient eligible for the treatment with LVIS™ Evo™ and HydroCoil® Embolic System (HES);
- •Patient whose target aneurysm is unruptured or ruptured (> 30 days since occurrence);
- •Patient whose target aneurysm size is less than or equal to 12 mm;
- •Patient willing to comply with all planned follow-ups and evaluations.
排除标准
- •EC 1 Patient who has suffered an intracerebral hemorrhage within 30 days prior to the procedure;
- •Patient whose target aneurysm is a fusiform aneurysm;
- •Patient whose target aneurysm has previously been treated with a stent;
- •Patient whose target aneurysm is partially thrombosed;
- •Patient whose target aneurysm requires Y stenting;
- •Patient whose target aneurysm is associated with an arteriovenous malformation (cAVM), or any other lesion that could lead to hemorrhagic complications;
- •Patient who has more than one aneurysm to be treated during the same procedure, (except in case of an adjacent aneurysm that could be treated with the same stent);
- •Patient for whom the treatment with another stent than LVIS™ Evo™ or in addition to LVIS™ Evo™ is planned;
- •Patient with a planned treatment of other aneurysm in the same vascular territory within 12 months;
- •Patient who has a known allergy to contrast agents (that cannot be adequately premedicated) and/or to the study device or procedure-required concomitant medications or procedures (e.g. contraindication to antiplatelet and/or anticoagulants, allergy to Nickel-titanium or contraindication to MRI/MRA or angiography);
- •Patient who has one of the following (as assessed prior to the index procedure): Other serious medical illness (e.g., cancer or any severe or fatal comorbidity) with estimated life expectancy of less than the study duration, OR Planned procedure that may cause non-compliance with the protocol or confound data interpretation;
- •Patient who is participating or intends to participate in another study that changes the site practice (interventional) within the study time period;
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Proportion of aneurysms with complete occlusion
时间窗: 12 ± 6-month
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory using digital subtraction angiograms (DSA)
次要结局
- RROC shift between immediate post procedure and each follow-up visit(30 ± 6 months)
- Percentage of HES coil length implanted in the target aneurysm(Day 0)
- Aneurysm occlusion stability between immediate post procedure and each follow-up visit(30 ± 6 months)
- Occurrence of target aneurysm recanalization at each follow-up(30 ± 6 months)
- Occurrence of procedural complications(Day 0)
- Proportion of patients with good functional clinical outcomes(30 ± 6 months)
- Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III, and Modified Raymond-Roy Classification at immediate post procedure and each follow-up visits(30 ± 6 months)
- Occurrence of in-stent stenosis or parent artery occlusion at each follow-up(30 ± 6 months)
- Major ipsilateral stroke or neurological death within 12 months and 30 months(30 ± 6 months)
- All-cause mortality rate(30 ± 6 months)
- Proportion of aneurysms with stent successful deployment at the target aneurysm neck(Day 0)
- Proportion of aneurysms with complete stent apposition(Day 0)
- Occurrence of target aneurysm retreatment at each follow-up(30 ± 6 months)
- Occurrence of subarachnoid hemorrhage(30 ± 6 months)
- Occurrence of Aneurysm rupture(30 ± 6 months)
- Occurrence of device-related serious adverse events(30 ± 6 months)
研究者
研究点 (19)
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