Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Atrium Advanta VXT and Flixene Vascular Grafts in Patients Undergoing Surgical Repair or Replacement of Peripheral Arteries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Percentage of Participants meeting Primary Efficacy Endpoint
研究概览
简要总结
The purpose of the registry is to evaluate the long-term safety and performance of Advanta VXT and Flixene vascular grafts for repair or replacement of peripheral arteries. This registry is also intended to provide further data on the clinical usefulness of the Advanta VXT and Flixene vascular grafts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 provide legally-effective written informed consent (as required by IRB/EC)
- •Male and female patients that have undergone replacement or repair of the peripheral arteries using the Advanta VXT or Flixene vascular graft.
- •Were at least 18 years of age at the time of the procedure
- •Available records for data collection, with a minimum of 36 months of data/follow-up.
排除标准
- •- Active infection in the region of graft placement at the time of implantation of the Advanta VXT or Flixene vascular graft
研究组 & 干预措施
Peripheral Arterial Disease (PAD) Cohort
干预措施: Advanta VXT Vascular Graft (Device)
Peripheral Arterial Disease (PAD) Cohort
干预措施: Flixene Vascular Graft (Device)
结局指标
主要结局
Percentage of Participants meeting Primary Efficacy Endpoint
时间窗: Procedure/surgery through registry completion (a minimum of 3 years)
Primary patency defined as freedom from graft occlusion or reintervention
Percentage of Participants meeting Primary Safety Endpoint
时间窗: Procedure/surgery through registry completion (a minimum of 3 years)
Major Adverse Limb Events (MALE), defined as major amputation or major reintervention, including placement of a new bypass graft, interposition graft, thrombectomy, or thrombolysis
次要结局
- Incidence of Reported Complications/Events(Procedure/surgery through registry completion (a minimum of 3 years))
- Percentage of Participants meeting Primary-Assisted Graft Patency(Procedure/surgery through registry completion (a minimum of 3 years))
- Percentage of Participants meeting Secondary Graft Patency(Procedure/surgery through registry completion (a minimum of 3 years))
- Rate of change in Rutherford Category(Baseline, procedure/surgery, through registry completion (a minimum of 3 years))
- Rate of change in Ankle-Brachial Index (ABI)(Baseline, procedure/surgery, through registry completion (a minimum of 3 years))