Status:
SUSPENDED
AndraValvulotome Post-Market Study
Lead Sponsor:
Andramed GmbH
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 peri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04815473
Start Date
April 28 2021
End Date
December 1 2023
Last Update
October 18 2023
Active Locations (4)
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1
University Clinic Augsburg
Augsburg, Germany
2
Evangelisches Krankenhaus Hubertus
Berlin, Germany, 14129
3
St. Bernward Krankenhaus
Hildesheim, Germany
4
University Clinic Leipzig
Leipzig, Germany