AndraValvulotome Post-Market Study - VSP-001

Andramed GmbH0 个研究点目标入组 70 人开始时间: 2021年7月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients with peripheral arterial disease who are planned to undergo a bypass surgery with autologous great saphenous vein 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 great saphenous vein with a length of at least 20cm /
•Rutherford category III - VI

•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 IF

发起方