NCT00543270已完成不适用
Endologix Powerlink Long-Term Follow-up Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 258
- 试验地点
- 14
- 主要终点
- All Cause Mortality
研究概览
简要总结
Endologix Infrarenal Bifurcated Stent Graft Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •All surviving patients from the original study cohort who received the Powerlink device
- •All surviving patients from the original study cohort who were assigned to the open surgical control arm
排除标准
- 未提供
研究组 & 干预措施
Endovascular Repair - EVAR (Powerlink System)
Experimental
EVAR (Powerlink System)
干预措施: Powerlink infrarenal bifurcated stent graft delivery system (Device)
Open Surgical Control
Active Comparator
Open Surgical Control
干预措施: Open Surgery (Procedure)
结局指标
主要结局
All Cause Mortality
时间窗: At 1 Year
No of deaths reported through 1 year
No of Subjects with Major adverse events
时间窗: At 1 Year
Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke
次要结局
- Aneurysm Morphology(Year 5)
- Clinical Utility Outcomes(up to 1 week)
- Stent Graft Performance(Year 5)
- Stent Graft Performance(30 Days)
- Stent Graft Performance(6 Months)
- Stent Graft Performance(Year 1)
- Stent Graft Performance(Year 2)
- Stent Graft Performance(Year 3)
- Stent Graft Performance(Year 4)
- Clinical Utility Outcomes(During the Procedure)
- Aneurysm Morphology(6 Months)
- Aneurysm Morphology(Year 1)
- Aneurysm Morphology(Year 2)
- Aneurysm Morphology(Year 3)
- Aneurysm Morphology(Year 4)
研究者
研究点 (14)
Loading locations...
相似试验
招募中
不适用
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"Stent-Graft StenosisAortic DiseasesThoracic Aortic DissectionStent-Graft EndoleakVascular DiseasesCardiovascular DiseasesThoracic Aortic AneurysmIntramural HematomaNCT05309707Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery100
已完成
2 期
AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia TreatmentPeripheral Artery DiseaseNCT00572494Flanders Medical Research Program117
已完成
不适用
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)Aortic Aneurysm, AbdominalVascular DiseasesAortic DiseasesCardiovascular DiseasesAneurysmAortic AneurysmNCT01526811Medtronic Cardiovascular180
尚未招募
不适用
Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive DiseasePeripheral Arterial DiseaseNCT04966767Shanghai Zhongshan Hospital800
已完成
不适用
Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent GraftIliac AneurysmAAANCT02692664JOTEC GmbH71