FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Occlusive Disease
- Sponsor
- Paracelsus Medical University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Incidence of primary patency of the venous bypass
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Klaus Linni
Head of Division of Vascular and Endovascular Surgery, MD PD
Paracelsus Medical University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of primary patency of the venous bypass
Time Frame: 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 Outcomes
- Incidence of limb salvage after procedure(2 years)
- Incidence of procedure-related mortality(2 years)
- Incidence of 30-day mortality(30 days)