Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06082466

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
110 (estimated)
Sponsor
Paracelsus Medical University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Patients presenting to Vascular Surgical Units are usually multimorbid with increased cardiopulmonary risk. Autologous venous bypass is indicated in certain situations despite the longer duration of surgery. Optimizing patency has been an important goal since many years. Reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies. This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. During this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. Due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.

Conditions

Interventions

TypeNameDescription
PROCEDUREFRAMED Infrainguinal Venous BypassThe harvested vein graft will be covered with a mesh.
PROCEDUREConventional Autologous BypassThe harvested vein graft will be used without a mesh coating.

Timeline

Start date
2023-09-11
Primary completion
2025-09-01
Completion
2027-09-01
First posted
2023-10-13
Last updated
2023-11-21

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT06082466. Inclusion in this directory is not an endorsement.