Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 15
- 主要终点
- Number of Participants With Disease or Treatment-related Morbidity and Mortality.
研究概览
简要总结
The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.
详细描述
This study is designed as a pragmatic trial. All candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. Unruptured aneurysms may be recently discovered or prevalent. If they accept, subjects will be randomized to one of the two arms of the trial: Conservative management (Observation) or Endovascular treatment.
Both groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. A non-invasive (MRA or CTA) or catheter angiogram and a baseline CT-scan or MRI of the brain are required to enter the study. These studies should demonstrate the unequivocal presence of a saccular aneurysm >=3 mm treatable by endovascular methods. A catheter angiogram is required if there is doubt. Imaging studies will be reviewed centrally. Both treatments will be standardized. Patients will be followed similarly for a minimum of 10 years.
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
- Single (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
- •At least one documented subarachnoid aneurysm, never ruptured
- •Patient aged 18 or older
- •Life expectancy more than 10 years
排除标准
- •Patients with recent (less than 3 months) intracranial haemorrhage
- •Lesion characteristics unsuitable for endovascular treatment
- •Patients with a single extradural aneurysm
- •Aneurysms < 3 mm or giant aneurysms (≥ 25 mm)
- •Patients with a poor outcome (Rankin scale ≥ 3) after the rupture, surgical or endovascular treatment of another aneurysm
- •Patients with incompletely treated aneurysms that have previously ruptured
- •Patients with associated arteriovenous malformations
- •Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
- •Patients with previous intracranial haemorrhage from unknown etiology
- •Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
- •Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
- •Pregnant patients
- •Patients unable to give informed consent
结局指标
主要结局
Number of Participants With Disease or Treatment-related Morbidity and Mortality.
时间窗: 1 year after treatment or observation
Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process. a "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.
次要结局
- Measures on 36-Item Short-Form Health Survey (SF-36)(At 5 and 10 years)
- Occlusion State of the Aneurysm in the Conservative Group(At 5 and 10 years)
- Number of Participants With Hemorrhage in Endovascular Group(At 1 year)
- Modified Rankin Score(At 10 years)
- Rate of Hemorrhage in Conservative Group(At 5 and 10 years)
- Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group(At 1 year)
- Occlusion State in the Endovascular Group(At 5 and 10 years)
- Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)(Baseline, 1 year, 5 and 10 years)