PRET: Patients Prone to Recurrence After Endovascular Treatment. A Randomized Trial Comparing Platinum and Hydrogel-coated Coils
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 447
- 试验地点
- 34
- 主要终点
- Recurrence Rate of Target Aneurysm.
研究概览
简要总结
The PRET study aims at comparing two types of coils used in the endovascular treatment of intracranial aneurysms. The first type made of platinum has been used for more than 15 years. The other, referred to as hydrocoil, containing in addition to platinum a polymer layer that expands when in contact with blood, has been in use since 2002. The hypothesis of the PRET study is that the newer hydrocoil will be more effective and yet as safe as the older platinum coil.
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
- Double (Participant, Outcomes Assessor)
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 'prone to recurrence after endovascular treatment' (PRET), defined for the sake of this study as:
- •PRET-1: One ruptured or unruptured aneurysm, never treated, with a dimension ≥10mm (longest axis, including thrombosed portions of large or giant aneurysms); for ruptured lesions, patients should be in WFNS grade I, II or III.
- •PRET-2: an Aneurysm presenting a major recurrence after previous coiling; and judged by the neurovascular team to require elective treatment.
- •The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable)
- •The endovascular physician is content to use either type of coils (platinum or hydrogel-coated coils) but no other type of coils
- •Patient is 18 or older
- •Life expectancy is more than 2 years
排除标准
- •Presence of other aneurysms requiring treatment during the same session
- •Patients with associated cerebral arteriovenous malformations
- •When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure
- •Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications
研究组 & 干预措施
1
platinum coils
干预措施: endovascular coil embolization (Procedure)
2
hydrogel coils
干预措施: endovascular coil embolization (Procedure)
结局指标
主要结局
Recurrence Rate of Target Aneurysm.
时间窗: 18 months
1. major angiographic recurrence of the lesion or the presence of a residual aneurysm at last angiographic follow-up, as determined by the core laboratory, blinded to treatment allocation; 2. retreatment of the same aneurysm by endovascular or surgical means during the 18-month follow-up period; 3. an intracranial bleeding episode, or the occurrence or progression of a mass effect in relation to the treated aneurysm during the follow-up period, as determined by the blinded Adverse Event Committee.
次要结局
- Number of Participants With Serious Adverse Events(18 months)
- Number of Participants With Adverse Events(18 months)
- Mortality Rate(18 months)