AndraValvulotome Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Absence of device related serious adverse events (SAE)
研究概览
简要总结
The AndraValvulotome Post-Market Study is a prospective, open-label, multi-center study to evaluate the efficacy and safety of the AndraValvulotome. A maximum of 70 patients will be enrolled with peripheral artery disease (PAD) in up to 10 sites. Study participants will be primarily observed during the bypass procedure. In addition, the patients will be re-evaluated at the follow-up visit which will be scheduled 30 +/- 7 days after beginning of the study participation.
The objective of this study is to analyze the efficacy and safety of the valvulotomy of the venous valves with the CE marked AndraValvulotome during the bypass procedure.
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
- •Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous vena saphena magna and using a valvulotome.
- •Patient has to be consented and a informed consent form needs to be signed.
- •Patient is able to and willing to participate in the 30 days follow-up.
- •Vein diameter is at least 2mm (4F system) and 3mm (5F system).
- •Vein diameter does not exceed 8mm (OTW-version) or 6mm (TIP-version)
- •Bypass needs to be a continuous vena saphena magna with a length of at least 20cm.
- •Rutherford category III - VI
排除标准
- •Patients who have not completed 18 years of age
- •Patients who are pregnant or assuming to be pregnant, and breast feeding.
- •Patients who cannot participate due to medical or physical condition based on the decision of the physician.
- •Life expectancy less than 1 year
- •Known allergies to materials of the tip, cutting basket, outer catheter, kink protection and braid.
- •Rutherford category 0-2
- •Using varicose vein
- •Exclusion criteria based on IFU
结局指标
主要结局
Absence of device related serious adverse events (SAE)
时间窗: until 30 +/- 7 days follow-up visit
Rate of not sufficiently incised venous valves
时间窗: Until approximately 10 days after procedure or discharge
Pulsatile blood flow
时间窗: during procedure
次要结局
- Severity of device related AE and SAE(until 30 +/- 7 days follow-up visit)
- Severity of device related bleeding(until 30 +/- 7 days follow-up visit)
- Primary patency rate(until 30 +/- 7 days follow-up visit)
- Primary technical success(Until approximately 10 days after procedure or discharge)
- Quantity of device related AE and SAE(until 30 +/- 7 days follow-up visit)
- Quantity of passages of valvulotomy(during procedure)
- Quantity of device related bleeding(until 30 +/- 7 days follow-up visit)