Clinical trial NCT06082466: FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Official title: FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Femoropopliteal Artery Occlusion
Femoropopliteal Stenosis
Critical Limb-Threatening Ischemia
Claudication, Intermittent
Keywords: Extraluminal Bypass Stenting
Autologous Vein Graft
Bypass Extremity Graft
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Incidence of primary patency of the venous bypass
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of procedure-related mortality
timeFrame: 2 years
measure: Incidence of 30-day mortality
timeFrame: 30 days
measure: Incidence of limb salvage after procedure
timeFrame: 2 years
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: University Hospital of Salzburg, Paracelsus Medical University
Study officials:
affiliation: Senior Physician
name: Stephan Koter, MD, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Resident Physician
name: Stephanie Rassam, MD
role: STUDY_DIRECTOR
affiliation: Head of Division
name: Klaus Linni, MD, PD, FEBVS
role: PRINCIPAL_INVESTIGATOR
References: