A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 30
- 主要终点
- Treatment Success at 12 Months Post-Implantation/surgery.
研究概览
简要总结
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.
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
- •Subject is > 18 years or minimum age as required by local regulations.
- •Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
- •Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
- •Subject intends to electively receive the Ovation™ or Ovation Prime™ 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 demonstrates high probability of non-adherence to physician's follow-up requirements.
- •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 at 12 Months Post-Implantation/surgery.
时间窗: 12 Months
The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.
次要结局
- Safety and Performance Endpoints(1, 6, &12 Months)