NCT01340612已完成不适用
Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
Centre hospitalier de l'Université de Montréal (CHUM)7 个研究点 分布在 2 个国家目标入组 205 人开始时间: 2011年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 7
- 主要终点
- Recurrence rate of target aneurysm
研究概览
简要总结
The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial
- •The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting
- •The endovascular physician is a priori content to use either type of technique
- •The patient has not previously been randomized into the trial
- •Treatment is elective
- •Patient is 18 or older
- •Life expectancy is more than 2 years
- •Patient has given fully informed consent and has signed consent form
排除标准
- •Other aneurysms requiring treatment during the same session
- •Patients with associated cerebral arteriovenous malformations
- •Patients with recently ruptured aneurysms
- •When parent vessel occlusion is the primary intent of the procedure
- •Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel
- •Patients with recurring, previously stented aneurysms
结局指标
主要结局
Recurrence rate of target aneurysm
时间窗: 12 months
rate of angiographic recurrence
次要结局
- Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events(30 days)
- Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%(12 months)
- Overall morbidity and mortality given by the modified Rankin Score(12 months)
- Rate of mortality and morbidity defined as the number of subjects with a disabling neurological events as measured by a modified Rankin Score greater than 2 during the follow-up period(12 months)
研究者
研究点 (7)
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