Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC
研究概览
简要总结
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
- •Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
- •An Informed Consent Form signed by Subject or legally authorized representative
- •Male or infertile female
- •Able to comply with protocol requirements including following-up
- •Life expectancy > 2 years
- •Age > 21 years
- •Surgical candidate
排除标准
- •Mycotic or ruptured aneurysm
- •Known concomitant thoracic aortic aneurysm which requires intervention
- •American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
- •Renal insufficiency defined or patient undergoing dialysis
- •New York Heart Association (NYHA) Functional Classification class IV
- •Dissected, heavily calcified, or heavily thrombosed landing zone(s)
- •Tortuous or stenotic iliac and/or femoral arteries
- •Participating in another investigational device or drug study within 1 year of treatment
- •Systemic infection which may increase the risk of endovascular graft infection
- •Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- •Planned concomitant surgical procedure or major surgery within 30 days of treatment date
- •Known history of drug abuse
- •Known sensitivities or allergies to the device materials
结局指标
主要结局
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC
时间窗: Through 6 month follow-up visit
Freedom from all of the following: * Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC). * Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory * Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
时间窗: 30 days post-treatment
Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.
次要结局
- Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)(Through 6 month follow-up visit)