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FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

NCT06082466 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-11-21

No results posted yet for this study

Summary

The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.

Conditions

  • Peripheral Arterial Occlusive Disease
  • Femoropopliteal Artery Occlusion
  • Femoropopliteal Stenosis
  • Critical Limb-Threatening Ischemia
  • Claudication, Intermittent

Interventions

PROCEDURE

FRAMED Infrainguinal Venous Bypass

The harvested vein graft will be covered with a mesh.

PROCEDURE

Conventional Autologous Bypass

The harvested vein graft will be used without a mesh coating.

Sponsors & Collaborators

  • Paracelsus Medical University

    lead OTHER

Principal Investigators

  • Stephan Koter, MD, PD · Senior Physician

  • Stephanie Rassam, MD · Resident Physician

  • Klaus Linni, MD, PD, FEBVS · Head of Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Austria

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 NCT06082466 on ClinicalTrials.gov