Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.
详细描述
Prospective single-arm multicenter registry
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AAA with one of following indications
- •AAA with maximum diameter > 5 cm,
- •AAA with maximum diameter > 4 cm with an increase >0.5 cm during the preceding 6 months
- •Saccular type AAA irrespective of the sac diameter.
- •Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
- •Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
- •Femoral access vessels should be adequate to fit the selected delivery system
- •Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
- •Aortic bifurcation >18 mm in diameter
- •Patents with age of 19-80 years.
- •Male or non-pregnant female
- •Voluntary participation in the study with signed informed consent form.
排除标准
- •Dissecting or ruptured abdominal aortic aneurysm
- •Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome).
- •Prior AAA or iliac artery repair
- •Active infection or active vasculitis.
- •Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment.
- •Need for renal artery coverage (e.g. Chimney graft)
- •Dialysis-dependent renal failure or serum creatinine >2.0 mg/dl
- •Intolerance/hypersensitivity to contrast media or antiplatelet drugs.
- •Positive pregnancy test.
- •Participation in another medical research study within 1 month of study enrolment.
- •Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
- •Patients with life expectancy less than 1 year
结局指标
主要结局
Technical success
时间窗: At the end of the procedure
Technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. Primary conversion or additional implantation of bare metal stent, aortic cuff or EndoAnchors to treat type I endoleak is considered a technical failure.
次要结局
- Major adverse event(1 year)
- Aneurysm-related death(1 year)
- Reintervention(1 year)
- Type I/III endoleaks(1 year)
- Aneurysm-related event(1 year)
- All vascular complications related to the INCRAFT device or aneurysm requiring surgical or endovascular interventions(30 days)
- Number of closure devices used for the closure of access sites.(30 days)