Endurant Evo US Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 139
- 试验地点
- 28
- 主要终点
- The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
研究概览
简要总结
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
详细描述
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- •Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
- •Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
- •Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of flow)
- •Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
- •Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging:
- •Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
- •Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
- •Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm
- •The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-uni-iliac stent graft (AUI)
- •Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system
- •Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifurcation and unilaterally for the AUI
排除标准
- •Subject has a life expectancy ≤1 year
- •Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- •Subject is pregnant
- •Subject has an aneurysm that is:
- •Suprarenal/pararenal/juxtarenal
- •Isolated ilio-femoral
- •Inflammatory
- •Pseudoaneurysm
- •Dissecting
- •Leaking but not ruptured
- •Subject requires emergent aneurysm treatment
- •Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
- •Subject has been previously treated for an abdominal aortic aneurysm
- •Subject has a history of bleeding diathesis or coagulopathy
- •Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft
- •Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
- •Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
- •Subject has a known allergy or intolerance to the device materials
- •Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
- •Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator
- •Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
- •Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or tortuosity
- •Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
- •Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion
- •Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
- •Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)
- •Subject is on dialysis
结局指标
主要结局
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
时间窗: 30-days
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
时间窗: 12-months
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
次要结局
- Aneurysm Rupture(within 183 and 365 days)
- All Endoleaks Based on Imaging Findings(at 1-, 6-, and 12-month follow-up visits)
- All-cause Mortality(within 30, 183, and 365 days)
- Secondary Procedures to Correct Type I and III Endoleaks(within 183, and 365 days)
- Serious Adverse Events(within 30, 183, and 365 days)
- Stent Graft Migration(At 6- and 12-month follow-up visits (as compared to 1-month imaging))
- Aneurysm-related Mortality (ARM)(within 30, 183, and 365 days)
- Conversion to Open Surgery(within 183, and 365 days)
- Aneurysm Expansion >5 mm(at 6- and 12-month follow-up visits (as compared to 1-month imaging))
- Device Deficiencies Based on Imaging Findings(Through 6- and 12 months)
- Secondary Procedures(within 183, and 365 days)
- Major Adverse Events(within 183 and 365 days)
- Stent Graft Occlusions Based on Imaging Findings(Through 1-, 6- and 12 months)