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AndraValvulotome Post-Market Study

NCT04815473 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-10-18

No results posted yet for this study

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 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.

Conditions

  • Peripheral Arterial Disease

Interventions

PROCEDURE

Valvulotomy

Valvulotomy of the venous valves

Sponsors & Collaborators

  • Andramed GmbH

    lead INDUSTRY

Principal Investigators

  • Alexander Hyhlik-Dürr, MD · University Clinic Augsburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2022-05-30
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815473 on ClinicalTrials.gov