Canadian Study on the Endovascular Treatment of Unruptured Intracranial Aneurysms Versus Surgical Treatment. A Randomized Comparison of Clinical and Angiographic Results of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 6
- 主要终点
- Treatment failure
研究概览
简要总结
Purpose:
Phase 1: (Pilot Phase)
To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms.
To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT.
To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible.
Phase 2:
To compare the results of surgical and endovascular management strategies, in terms of:
- Overall mortality and morbidity at 1 and 5 years.
- The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years
Hypotheses: Phase 1 Hypotheses:
- Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure.
- An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible.
Phase 1 Primary End-points:
• Treatment failure, hereby defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period.
Phase 1 Secondary End-points:
- Overall morbidity and mortality at one year.
- Occurrence of morbidity (mRS >2) or mortality following treatment.
- Occurrence of failure of aneurysm occlusion using the initial intended treatment modality.
- Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
- Occurrence of an intracranial hemorrhage following treatment.
- Peri-treatment hospitalization lasting more than 5 days
- Discharge following treatment to a location other than home
Treatment:
Trial feasibility, or the capacity for patient recruitment, would require enrollment of at least 8 patients per actively recruiting center per year.
Phase 2 Hypotheses:
It may be too early to explicitly define the primary hypothesis of Phase 2, however, the intent of Phase 2 can be expressed as:
- One management strategy is superior to the other in terms of clinical outcome at five years.
- One management strategy is superior to the other in terms of clinical efficacy at five years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients at least 18 years of age with at least 10 years of remaining life expectancy
- •At least one documented, intradural, saccular intracranial aneurysm
- •The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team
- •Aneurysm size 3-25 mm
排除标准
- •Patients with any intracranial hemorrhage, including SAH, within the previous 30 days
- •Lesion characteristics not readily suitable for either endovascular or surgical treatment, in the opinion of the physician(s) intending to treat the aneurysm
- •Multiple aneurysms, where the treatment plan includes both surgical clipping as well as endovascular coiling
- •Aneurysm anticipated (pre-operatively) to require proximal vessel occlusion, a bypass, or other flow-redirecting therapy (such as flow-diverting stents) as part of treatment plan
- •Patients with baseline mRS >2
- •Patients with a single cavernous aneurysm
- •Patients with dissecting, fusiform, or mycotic aneurysms
- •Patients with AVM-associated aneurysms
- •Pregnant patients (randomization (and treatment) may be delayed until after delivery)
- •Patients with absolute contraindications to anaesthesia, endovascular treatment or administration of contrast material, including low-osmolarity agents or gadolinium
- •Patients unable to give informed consent
结局指标
主要结局
Treatment failure
时间窗: One Year
Defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period.
次要结局
- Failure of aneurysm occlusion(1 year)
- Occurrence of a "major" (saccular) angiographic aneurysm recurrence.(1 year)
- Discharge following treatment to a location other than home(6-weeks post-treatment)
- Occurrence of morbidity (mRS >2) or mortality following treatment.(6 weeks post-treatment)
- Morbidity and mortality: 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting.(one year)
- Occurrence of an intracranial hemorrhage(1 year)
- Hospitalization lasting more than 5 days(6-weeks post-treatment)