FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FRAMED Infrainguinal Venous Bypass, Conventional Autologous Bypass.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure FRAMED Infrainguinal Venous Bypass
The harvested vein graft will be covered with a mesh. - Procedure Conventional Autologous Bypass
The harvested vein graft will be used without a mesh coating.
Primary outcome measures
- Incidence of primary patency of the venous bypass [Time frame: 2 years]
Secondary outcome measures (3)
- Incidence of procedure-related mortality [Time frame: 2 years]
- Incidence of 30-day mortality [Time frame: 30 days]
- Incidence of limb salvage after procedure [Time frame: 2 years]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- Pregnant or breastfeeding women
- Active infection or sepsis
- Acute ischemia
- Endovascular procedure in the region to be treated.
- Vein with outer diameter <3.5 mm or >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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- University Hospital of Salzburg, Paracelsus Medical University — Salzburg
Identifiers
NCT: NCT06082466 · 1144/2022