FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial (Framed IVB)

Paracelsus Medical University (PMU)

Status: Enrolling

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

Treatments: Procedure: FRAMED Infrainguinal Venous Bypass; Procedure: Conventional Autologous Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT06082466

1144/2022

Details and patient eligibility

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Conventional Autologous Bypass

Active Comparator group

Treatment:

Procedure: Conventional Autologous Bypass

FRAMED Infrainguinal Venous Bypass

Active Comparator group

Treatment:

Procedure: FRAMED Infrainguinal Venous Bypass