Actively Recruiting
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Led by Paracelsus Medical University · Updated on 2023-11-21
110
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the success of patency after autologous infrainguinal bypass surgery in patients with peripheral arterial occlusive disease and related conditions. The trial compares two surgical approaches: a traditional venous conduit versus a venous conduit covered with a mesh. The goal is to see if covering the harvested vein can reduce complications like intimal hyperplasia, which has been shown to affect the longevity of the bypass. Participants will be randomly assigned to either receive a conventional autologous bypass where the vein graft is used without a mesh, or the FRAMED infrainguinal venous bypass where the harvested vein graft is covered with a mesh. The study is conducted at a university hospital vascular surgery division. Follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 2 years after surgery to monitor the outcomes. During the trial, participants will undergo regular assessments to evaluate the primary measure of vein graft patency over two years. Secondary outcomes include procedure-related mortality within two years, mortality within 30 days, and limb salvage rates after the procedure. Participants will be monitored closely during these follow-ups to track the success and safety of the surgical methods over time.
CONDITIONS
Brief Title
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years
- Signed informed consent form
- Rutherford Category 3 (less than 200m walking distance) or chronic critical ischemia (Rutherford Category 4-6)
- Assured inflow and recipient artery suitable for bypass surgery
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection or sepsis
- Acute ischemia
- Recent endovascular procedure in the region to be treated
- Vein with outer diameter less than 3.5 mm or greater than 8 mm under pressure
- Use of spliced veins
- Known allergy to cobalt-chromium alloy or its components
- Vasculitis
- Coagulopathy
- Radiation therapy near the surgical connection site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus hospital recovery period
Participants undergo surgery to receive either a mesh-covered venous bypass or a conventional autologous bypass, followed by immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 2 years after surgery
Participants are monitored to assess the success of the bypass and recovery, with follow-up visits scheduled at regular intervals.
Follow-up visits at 6 weeks, 3 months, 6 months, 12 months, and 2 years
Trial Site Locations
Total: 1 location
1
University Hospital of Salzburg, Paracelsus Medical University
Salzburg, Austria, 5020
Actively Recruiting
Research Team
S
Stephanie Rassam, MD
S
Stephan Koter, MD, PD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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