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Compares treatment options for Peripheral Arterial Occlusive Disease
Official title FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
ClinicalTrials.gov ID: NCT06082466
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age at least 18 years
- Informed consent form with signature
- Rutherford Category 3 (\<200m) or chronic critical ischemia (Rutherford Category 4-6)
- Assured inflow and recipient artery.
You likely can't join if
- Pregnant or breastfeeding women
- Active infection or sepsis
- Acute ischemia
- Endovascular procedure in the region to be treated.
- Vein with outer diameter \ 8 mm under pressure.
- Spliced Veins.
See the full eligibility criteria
- Age at least 18 years
- Informed consent form with signature
- Rutherford Category 3 (\<200m) or chronic critical ischemia (Rutherford Category 4-6)
- Assured inflow and recipient artery.
- Pregnant or breastfeeding women
- Active infection or sepsis
- Acute ischemia
- Endovascular procedure in the region to be treated.
- Vein with outer diameter \ 8 mm under pressure.
- Spliced Veins.
- Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).
- Vasculitis
- Coagulopathy
- Radiation therapy near the anastomosis
The study team makes the final eligibility decision.
Where it's taking place
- Salzburg, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salzburg, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.