FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

NCT06082466 | Recruiting

• 1 other identifier: 1144/2022
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of procedure-related mortality

  2 years

• Incidence of 30-day mortality

  30 days

• Incidence of limb salvage after procedure

  2 years

Study Arms (2)

Conventional Autologous Bypass

ACTIVE COMPARATOR

Procedure: Conventional Autologous Bypass

FRAMED Infrainguinal Venous Bypass

ACTIVE COMPARATOR

Procedure: FRAMED Infrainguinal Venous Bypass

Interventions

FRAMED Infrainguinal Venous Bypass PROCEDURE

The harvested vein graft will be covered with a mesh.

FRAMED Infrainguinal Venous Bypass

Conventional Autologous Bypass PROCEDURE

The harvested vein graft will be used without a mesh coating.

Conventional Autologous Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, 5020, Austria

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1; Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Koter, MD, PD

  Senior Physician

  PRINCIPAL INVESTIGATOR

• Stephanie Rassam, MD

  Resident Physician

  STUDY DIRECTOR

• Klaus Linni, MD, PD, FEBVS

  Head of Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Rassam, MD

CONTACT

+43 572550 57506; s.rassam@salk.at

Stephan Koter, MD, PD

CONTACT

+43 572550 55677; s.koter@salk.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Vascular and Endovascular Surgery, MD PD

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 13, 2023
• Study Start: September 11, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

AU (1)