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临床试验/NCT02461524
NCT02461524终止不适用

Endurant Evo International Clinical Trial

Medtronic Cardiovascular11 个研究点 分布在 5 个国家目标入组 69 人开始时间: 2015年6月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
69
试验地点
11
主要终点
Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.

详细描述

The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm 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 CT 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 (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 bilaterally 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 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 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

Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.

时间窗: 30 days

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

Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.

时间窗: Index procedure

Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), 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

次要结局

  • Number of Subject With Device Deficiencies Based on Imaging Findings(Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month)
  • The Number of Subjects With Conversion to Ppen Surgery(Within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • Number of Subjects With All-Cause Mortality (ACM) at Each Follow up(Within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point(within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point(Within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • The Number of Subjects With Major Adverse Events (MAE)(Within 183, and 365 days, then annually until 5-Year post-implantation)
  • The Number of Subjects With Aneurysm Rupture(Within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)(Through 12-month, 24-month, 36-month, 48-month and 60-month)
  • Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)(12-month, 24-month, 36-month, 48-month and 60-month)
  • Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point(within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • Number of Subjects With Serious Adverse Events (SAE)(within 30, 183, and 365 days, then annually until 5-Year post-implantation)
  • Number of Subjects With Stent Graft Occlusion Based on Imaging Findings(Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month)
  • Number of Subject With Endoleaks Based on Imaging Findings(1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month)

研究者

发起方
Medtronic Cardiovascular
申办方类型
Industry
责任方
Sponsor

研究点 (11)

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