LARGE Aneurysm Randomized Trial: Flow Diversion Versus Traditional Endovascular Coiling Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.
研究概览
简要总结
In this study, patients with large anterior circulation IAs with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion will be randomly assigned to either treatment technique.
详细描述
This is a prospective, randomized trial comparing the endovascular coiling (endovascular coiling) versus the flow diversion for large and giant aneurysm treatment. The endovascular coiling used in this study are FDA-approved and in common use at institutions in this country and across the world. The flow diversion devices are FDA-approved for anterior circulation aneurysms >10 mm and are in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to treatment with either endovascular coiling or flow diversion. Data on each patient will be collected at the time of enrollment and treatment, and at subsequent follow-up visits.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Coiling
Coiling
干预措施: Coiling (Procedure)
Flow Diversion
Flow Diversion
干预措施: Flow Diversion (Procedure)
结局指标
主要结局
The primary aim of aneurysm treatment is to achieve occlusion of the IA without morbidity or mortality.
时间窗: approaximately 180 days after aneurysm treatement procedure
Greater than 90% angiographic occlusion AND stable (or decreased) aneurysm size on cross sectional imaging (CT or MR) at 180 days post procedure. The primary objective is to show that flow diversion is non-inferior to endovascular coiling with respect to a combined efficacy and safety endpoint.
次要结局
- Subgroup analysis of clinical and angiographic outcomes in aneurysms 10-20 mm and > 2 cm.(approximately 3 years after aneurysm treatment procedure)
- Incidence of device or procedure related adverse events at 180 days, 1 year and 3 years.(approximately 90 days, 180 days, 1 year, 2 year and 3 year)
- Downstream flow related ischemic stroke, parenchymal hemorrhage, subarachnoid hemorrhage, aneurysm rupture or re-treatment of index aneurysm rates at 180 days, one year and 3 years.(approaximately 180 days, 1 year, and 3 years after aneurysm treatement procedure)
- Change in clinical functional outcome at 180 days, 1 year and 3 years post-endovascular treatment procedure, as measured by an increase in the modified Rankin Scale from baseline.(180 days, 1 year and 3 years post-endovascular treatment procedure)
- Incidence of worsening of baseline neurological signs/symptoms as measured by NIHSS/ophthalmologist exam related to target intracranial aneurysm (IA) at 180 days.(180 days)
- Number of inpatient hospital (and re-hospitalized) days (subgrouped >7 days) at 180 days, 1 year and 3 years.(180 days, 1 year and 3 years.)
- Packing density as measured by volumetric filling of the aneurysm if aneurysm is coiled.(after initial procedure, day 0)
- Device cost of therapy at treatment and any subsequent retreatment.(approximately 6 years after the initial procedure)
- Procedure time, as measured as the time from placement of the treating guide catheter for purposes of aneurysm treatment until guide catheter removal.(approximately 6 years after the initial procedure)
- Subgroup analysis of clinical and angiographic outcomes in aneurysms intradural vs. extradural location(approximately 3 years after aneurysm treatment procedure)
- Subgroup analysis of clinical and angiographic outcomes in aneurysms reconstructive vs. deconstructive technique.(approximately 3 years after aneurysm treatment procedure)