Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac 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
- 338
- 试验地点
- 40
- 主要终点
- Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.
研究概览
简要总结
The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.
详细描述
This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US.
The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Willing and able to comply with all study procedures and visits.
- •Written informed consent to participate in the study.
- •Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System.
- •Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.
排除标准
- •Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.
研究组 & 干预措施
Subjects who receive the TREO Abdominal Stent-Graft System
Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.
干预措施: TREO Abdominal Stent-Graft System (Device)
结局指标
主要结局
Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.
时间窗: Through 5 Years post-procedure
Incidence of fracture in a stent-strut or separation of one or more proximal fixation barbs as confirmed by the Imaging Core Laboratory upon review of post-implant imaging studies.
Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.
时间窗: Through 5 Years post-procedure
Incidence of secondary intervention for adverse events related to or caused as a result of a fracture in a stent-strut or separation of one or more proximal fixation barbs. Relatedness to the device will be confirmed by the Clinical Events Committee (CEC) through review of available treatment and procedure records and reports of imaging studies.
次要结局
- Incidence of all-cause mortality(Through 5 Years post-procedure)
- Incidence of Type I, II, III, IV or V Endoleaks(Through 5 Years post-procedure)
- Incidence of aneurysm-related mortality(Through 5 Years post-procedure)
- Incidence of secondary interventions.(Through 5 Years post-procedure)
- Incidence of procedure-related clinical utility measures(Through 5 Years post-procedure)
- Incidence of aneurysm rupture(Through 5 Years post-procedure)
- Incidence of loss of device integrity(Through 5 Years post-procedure)
- Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging).(Through 5 Years post-procedure)
- Incidence of procedure-related complications(Through 5 Years post-procedure)
- Number of participants with technical success at the conclusion of the index procedure(Through 5 Years post-procedure)
- Major Adverse Events(Through 5 Years post-procedure)
- Incidence of successful aneurysm treatment(12 months post-implant)
- Incidence of conversion to open surgical repair.(Through 5 Years post-procedure)
- Incidence of device stenosis or kink(Through 5 Years post-procedure)
- Incidence of stent-graft migration (>10mm as compared to 30-day imaging)(Through 5 Years post-procedure)
- Incidence of stent-graft occlusion (i.e., loss of patency)(Through 5 Years post-procedure)