Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
- 试验地点
- 102
- 主要终点
- Number of Subjects Free From Primary Safety Endpoint Event
研究概览
简要总结
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
详细描述
The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy.
This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AAA meeting any of the following criteria:
- •Maximum diameter ≥50 mm
- •Rapid growth (>5 mm in a 6 month period)
- •Non-ruptured AAA presenting with clinical symptoms
- •Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
- •Adequate iliac / femoral access
- •Infrarenal aortic neck diameter 16-32 mm
- •Infrarenal aortic neck length ≥10 mm
- •Aortic neck angle ≤ 90˚
- •Distal iliac artery seal zone ≥10 mm
- •Iliac artery diameter 8-25 mm
- •An Informed Consent Form (ICF) signed by Subject
- •Male or infertile female
- •Able to comply with Protocol requirements including following-up
- •Life expectancy > 2 years
- •Age ≥ 21 years
排除标准
- •Mycotic or ruptured aneurysm
- •Known concomitant thoracic aortic aneurysm which requires surgical intervention
- •Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
- •New York Heart Association (NYHA) class IV
- •Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
- •Severely tortuous or stenotic iliac and / or femoral arteries
- •Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
- •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
Number of Subjects Free From Primary Safety Endpoint Event
时间窗: 30 Days
The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)
Number of Subjects With Device Treatment Success
时间窗: 12 Months
The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: * Type I endoleak in the 12 month window * Type III endoleak in the 12 month window * Migration (10 mm or more) at the 12 month window (relative to post-operative baseline) * AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline) * AAA rupture through the 12 month window * Conversion to open repair through the 12 month window
次要结局
- Number of Subjects With Abdominal Aortic Aneurysm Rupture(5 years)
- Number of Subjects With Reintervention(5 years)
- Number of Subjects With Significant Index Procedure Blood Loss(Procedure Day)
- Number of Subjects With Type I Endoleak(5 years)
- Number of Subjects With Type IV Endoleak(5 years)
- Number of Subjects With Severe Myocardial Infarction(5 years)
- Number of Subjects With Type III Endoleak(5 years)
- Number of Subjects With AAA Enlargement ≥5 mm(5 years)
- Number of Subjects With Type II Endoleak(5 years)
- Number of Subjects With Severe Stroke(5 years)
- Number of Subjects With Severe Renal Failure(5 years)
- Number of Subjects With Stent Fracture(5 years)
- Number of Subjects With Aneurysm-related Mortality(5 years)
- Median Hospital Stay(Through initial hospital discharge)
- Number of Subjects With Severe Paraplegia(5 years)
- Number of Subjects With Conversion to Open Repair(5 years)
- Median Index Procedure Time(Procedure Day)
- Number of Subjects With Severe Bowel Ischemia(5 years)
- Number of Subject Deaths(5 years)
- Number of Subjects With Severe Respiratory Failure(5 years)
- Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events)(5 years)
- Number of Subjects With Migration(5 years)
- Median Procedural Blood Loss (mL)(Procedure Day)
- Technical Success(Procedure Day)