Endurant Stent Graft System US Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 58
- 主要终点
- Major Adverse Events Within 30 Days of Index Procedure
研究概览
简要总结
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
详细描述
Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.
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
- •Subject is ≥ 18 years old.
- •Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
- •Subject is able and willing to comply with the protocol and undergo follow-up requirements.
- •Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
- •Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
- •Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
- •Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
- •Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
- •Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.
排除标准
- •Subject has a life expectancy < 1 year
- •Subject is participating in another investigational drug or device study
- •Subject requires emergent aneurysm treatment
- •Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
- •Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- •Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
结局指标
主要结局
Major Adverse Events Within 30 Days of Index Procedure
时间窗: 30 days
The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke
Primary Effectiveness Endpoint (Treatment Success)
时间窗: 12 months
Treatment success is defined as Technical success and the following: * Freedom from AAA diameter increased, defined as \>5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month * Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months * Freedom from aneurysm rupture through 12 months * Freedom from conversion to surgery through 12 months * Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months * Freedom from stent graft occlusion at 12 months
Primary Effectiveness Endpoint (Technical Success)
时间窗: Intra-operatively
Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.
Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)
时间窗: 30 days (Safety)
The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. * All-Cause Mortality * Bowel Ischemia * Myocardial Infarction * Paraplegia * Procedural Blood Loss \> or equal to 1000 cc * Renal Failure * Respiratory Failure * Stroke
次要结局
- Secondary Endpoints - Safety Evaluation(12 months)
- Secondary Endpoint - Effectiveness Evaluation(12 months)