Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment success
研究概览
简要总结
This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 of age
- •Both IFU and non-adherence to IFU
- •Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
- •Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan
排除标准
- •Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
- •Life expectancy less than 1 year
- •Pregnancy
- •Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
结局指标
主要结局
Treatment success
时间窗: 12 months
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration \> 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement \>5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
次要结局
- Abdominal aortic aneurysm sac enlargement(1 and 12 months)
- Number and Classification of Endoleaks(1 and 12 months)
- Number of Secondary Interventions(1 and 12 months)
- Device-related Adverse Events (AEs)(1 and 12 months)
- Stent Graft Migration(1 and 12 months)
- Aortic neck alteration(1 and 12 months)
- Freedom from abdominal aortic aneurysm rupture(1 and 12 months)
- Major adverse events(1 and 12 months)
- Adherence to instruction for use(12 months)
- AAA-related mortality(1 and 12 months)
研究者
Konstantinos Spanos
Principal Investigator
Larissa University Hospital