AndraValvulotome Post-Market Study

Andramed

Status

Suspended

Conditions

Peripheral Arterial Disease

Treatments

Procedure: Valvulotomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04815473

VSP-001

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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