Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure.
研究概览
简要总结
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.
详细描述
Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.
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
- •Patient's age ≥ 18 years old
- •Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
- •No prior treatment of the aneurysm
- •Agreement for participating in the study and informed consent signed by the patient
- •Patient affiliated to a social security scheme
排除标准
- •Patient's age < 18 years old
- •Adult patient protected by law
- •Contraindications to the endovascular procedure
- •Contraindications to antiplatelet or anticoagulant treatment
- •Prior treatment of the aneurysm
- •Presence of an arteriovenous malformation
- •Extradural location of the aneurysm
- •Fusiform aneurysm
- •Active bacterial infection (clinical signs)
- •Intracranial hemorrhage from aneurysm in the previous month
- •Pregnant or breastfeeding woman
研究组 & 干预措施
PIPELINE flow diverter stent
flow diverter stent
干预措施: PIPELINE flow diverter stent (Device)
PIPELINE flow diverter stent
flow diverter stent
干预措施: Coils, with or without expendable stent (Device)
Coils, with or without expendable stent
Coils
干预措施: PIPELINE flow diverter stent (Device)
Coils, with or without expendable stent
Coils
干预措施: Coils, with or without expendable stent (Device)
结局指标
主要结局
Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure.
时间窗: 12 months
次要结局
- Incremental cost-effectiveness ratio(12 months)
- Occurrence of a death during or after endovascular procedure(hospitalization for the endovascular procedure, up to 7 days)
- Occurrence of a death whatever the cause(24 months)
- Occurrence of a death due to aneurysm rupture(24 months)
- Occurrence of an intracranial hemorrhagic from rupture of the aneurysm(24 months)
- Occurrence of an ischemic stroke due to thrombosis(24 months)
- Occurrence of a non-cerebral bleeding(24 months)
- National Institute of Health Stroke Score (NIHSS)(Inclusion, 3 months and 12 months)
- Evolution of the Barthel index(: Inclusion and 12 months)
- Retreatment of the aneurysm(24 months)
- Rate of technical complications(Endovascular procedure an expected average of 1 hour)
- Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others(Endovascular procedure an expected average of 1 hour)
- Rate of correct placement of flow diverter stents, according to the investigator(Endovascular procedure an expected average of 1 hour)
- mean duration of irradiation related to angiography(Endovascular procedure an expected average of 1 hour)
- Rate of patients for each class of occlusion(Endovascular procedure , an expected average of 1 hour and 12 months)
- Modified Rankin score(Inclusion, 3 months and 12 months)
- Rate of patients with neurological deficits by mass effect(hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention)