Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression
概览
- 阶段
- 不适用
- 干预措施
- Medtronic Endurant II or Endurant IIs Stent Graft System
- 疾病 / 适应症
- Abdominal Aortic Aneurysm
- 发起方
- Medtronic Cardiovascular
- 入组人数
- 600
- 试验地点
- 69
- 主要终点
- Sac Regression
- 状态
- 招募中
- 最后更新
- 24天前
概览
简要总结
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.
详细描述
This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. Product Names: * Medtronic Endurant II/IIs Stent Graft System * Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.
研究者
入排标准
入选标准
- •Subject and the treating physician agree that the subject will return for all required follow up visits
- •Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board
- •Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.
- •Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.
排除标准
- •Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
- •Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
- •Subject has an aneurysm that is:
- •Suprarenal/pararenal/juxtarenal
- •Isolated ilio-femoral
- •Inflammatory
- •Pseudoaneurysm
- •Concomitant or prior dissection involving the abdominal aorta or iliac arteries
- •Symptomatic AAA
- •Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.
研究组 & 干预措施
Medtronic Endurant II/IIs
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
干预措施: Medtronic Endurant II or Endurant IIs Stent Graft System
Gore Excluder / Excluder Conformable
Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.
干预措施: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
结局指标
主要结局
Sac Regression
时间窗: 12 months
Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.
次要结局
- Secondary intervention incidence rate(30 days, 12 months and annually to 5 years)
- Type II endoleak incidence rate(30 days, 12 months and annually to 5 years)
- Type I endoleak incidence rate(30 days,12 months and annually to 5 years)
- All cause mortality incidence rate(30 days, 12 months and annually to 5 years)
- Aneurysm sac change by volume incidence rate(12 months and annually to 5 years)
- Aneurysm sac change by diameter as a continuous variable(12 months and annually to 5 years)