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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Occlusive Disease; Claudication, Intermittent; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia
• Intervention / Treatment: Procedure: Conventional Autologous Bypass; Procedure: FRAMED Infrainguinal Venous Bypass

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Rassam, MD; Phone Number: +43 572550 57506; Email: s.rassam@salk.at
• Study Contact Backup: Name: Stephan Koter, MD, PD; Phone Number: +43 572550 55677; Email: s.koter@salk.at

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Recruiting
    • University Hospital of Salzburg, Paracelsus Medical University
    • Contact: Klaus Linni, MD PD; Email: k.linni@salk.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Investigators: Principal Investigator: Stephan Koter, MD, PD, Senior Physician; Study Director: Stephanie Rassam, MD, Resident Physician; Principal Investigator: Klaus Linni, MD, PD, FEBVS, Head of Division

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Extraluminal Bypass Stenting; Autologous Vein Graft; Bypass Extremity Graft
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Ischemia; Intermittent Claudication; Arterial Occlusive Diseases
• Other Study ID Numbers: 1144/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No