AndraValvulotome Post-Market Study
- Conditions
- I70.22I70.23I70.24I70.25peripheral arterial disease
- Registration Number
- DRKS00025919
- Lead Sponsor
- Andramed GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 70
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absence of device related serious adverse events (SAE)<br>[Time Frame: until 30 +/- 7 days follow-up visit]<br>/ Rate of not sufficiently incised venous valves<br>[Time Frame: Until approximately 10 days after procedure or discharge]<br>/ Pulsatile blood flow<br>[Time Frame: during procedure]
- Secondary Outcome Measures
Name Time Method Quantity of device related bleeding / Severity of device related bleeding / Quantity of device related AE and SAE / Severity of device related AE and SAE / Quantity of passages of valvulotomy / Primary patency rate / Primary technical success