FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Not Applicable

Recruiting

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

• Registration Number: NCT06082466
• Lead Sponsor: Paracelsus Medical University

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-04
• Study Start: 2023-09-11
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of primary patency of the venous bypass	2 years	The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass.

Secondary Outcome Measures

Name	Time	Method
Incidence of limb salvage after procedure	2 years	Amputation free survival
Incidence of procedure-related mortality	2 years	Mortality intervention-related
Incidence of 30-day mortality	30 days	Number of participants, who die within 30 days after the procedure.

Trial Locations

Locations (1)

University Hospital of Salzburg, Paracelsus Medical University; 🇦🇹 Salzburg, Austria