FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Conditions
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Peripheral Arterial Occlusive Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis, Critical Limb-Threatening Ischemia, Claudication, Intermittent

Intervention / Treatment
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* Procedure: FRAMED Infrainguinal Venous Bypass
* Procedure: Conventional Autologous Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Autologous Bypass<br> | Procedure: Conventional Autologous Bypass<br>* The harvested vein graft will be used without a mesh coating.<br>|
| Active Comparator: FRAMED Infrainguinal Venous Bypass<br> | Procedure: FRAMED Infrainguinal Venous Bypass<br>* The harvested vein graft will be covered with a mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of primary patency of the venous bypass | The incidence of patency of the venous bypasses will be analysed and compared. This is defined as freedom from occlusion of the venous bypass. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure-related mortality | Mortality intervention-related | 2 years | 
| Incidence of 30-day mortality | Number of participants, who die within 30 days after the procedure. | 30 days | 
| Incidence of limb salvage after procedure | Amputation free survival | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extraluminal Bypass Stenting, Autologous Vein Graft, Bypass Extremity Graft