FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Peripheral Arterial Occlusive Disease Clinical Trial

— Framed IVB  

Official title:

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082466
• Other study ID #: 1144/2022
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Paracelsus Medical University
• Contact: Stephanie Rassam, MD
• Phone: +43 572550 57506
• Email: s.rassam[@]salk.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Claudication, Intermittent
• Femoropopliteal Artery Occlusion
• Femoropopliteal Stenosis
• Intermittent Claudication
• Ischemia
• Peripheral Arterial Occlusive Disease

Intervention

Procedure:
• FRAMED Infrainguinal Venous Bypass
The harvested vein graft will be covered with a mesh.
• Conventional Autologous Bypass
The harvested vein graft will be used without a mesh coating.

Locations

Country	Name	City	State
Austria	University Hospital of Salzburg, Paracelsus Medical University	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of procedure-related mortality	Mortality intervention-related	2 years
Secondary	Incidence of 30-day mortality	Number of participants, who die within 30 days after the procedure.	30 days
Secondary	Incidence of limb salvage after procedure	Amputation free survival	2 years