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
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 limb ischemia (Rutherford Category 4-6)
- Assured inflow and recipient artery suitable for bypass
You will not qualify if you...
- Pregnant or breastfeeding women
- Active infection or sepsis
- Acute ischemia
- Prior endovascular procedure in the treated region
- Vein with outer diameter less than 3.5 mm or greater than 8 mm under pressure
- Spliced veins
- Known allergy to cobalt-chromium alloy or its components
- Vasculitis
- Coagulopathy
- Radiation therapy near the anastomosis area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Stephan Koter, MD, PD
CONTACT
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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