A Multicenter, Open Label, Prospective, Post-Market Study of the INCRAFT AAA Stent Graft in Subjects With Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Absence of major adverse events
研究概览
简要总结
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.
详细描述
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate. Subjects will be enrolled and followed at 1 month and 1 year post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female aged 18 and over
- •The femoral access vessel is adequate for the selected delivery system;
- •Length of proximal aneurysmal neck ≥ 10mm;
- •Aortic neck diameter ≥ 17mm and ≤ 31mm;
- •The aortic neck is suitable for suprarenal fixation;
- •The angle of the infrarenal and suprarenal neck is ≤60 degrees;
- •Iliac fixation length ≥ 15mm;
- •Iliac diameter ≥ 7mm and ≤ 22mm;
- •Minimum total AAA treatment length (proximal landing point to distal landing point) ≥ 128mm;
- •Morphology is suitable for aneurysm repair;
- •Written informed consent form shall be provided prior to initiating any study protocol;
- •The subject is willing to follow the prescribed follow-up schedule.
排除标准
- •The subject has one of the following conditions:
- •Aneurysm sac rupture or leaking abdominal aortic aneurysm
- •Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;
- •Known to be allergic or intolerant to nickel titanium (Nitinol), polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE);
- •Known contraindication to undergoing angiography or anticoagulation
- •Existing AAA surgical graft and/or a AAA stent-graft system;
- •Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial;
结局指标
主要结局
Absence of major adverse events
时间窗: Within 30-days post-procedure
MAE is defined as the combination of death, myocardial infarction, stroke/cerebrovascular accident, and renal failure.
次要结局
- Occurence of major adverse events(Through 1 year post-procedure)
- Technical success(At the conclusion of the index procedure)
- Absence of stent graft migration(>10mm)(Assessed at 1 year)
- Absence of Type I or Type III endoleak and no aneurysm enlargement (growth >5mm)(Assessed at 1 year compared to size measurement at 1 month)
- Absence of stent graft fracture(Assessed within 30-days and 1-year post-procedure)
- Absence of stent occlusion (including unilateral or bilateral limb occlusion) and aneurysm sac rupture(Within 1-year post-procedure)
- Absence of all-cause mortality and aneurysms-related death(Within 1-year post-procedure)