MedDataX Logo

FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

NCT ID: NCT06082466

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Autologous Bypass

Group Type ACTIVE_COMPARATOR

Conventional Autologous Bypass

Intervention Type PROCEDURE

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

FRAMED Infrainguinal Venous Bypass

Group Type ACTIVE_COMPARATOR

FRAMED Infrainguinal Venous Bypass

Intervention Type PROCEDURE

The harvested vein graft will be covered with a mesh.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FRAMED Infrainguinal Venous Bypass

The harvested vein graft will be covered with a mesh.

Intervention Type PROCEDURE

Conventional Autologous Bypass

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Paracelsus Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Klaus Linni

Head of Division of Vascular and Endovascular Surgery, MD PD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephan Koter, MD, PD

Role: PRINCIPAL_INVESTIGATOR

Senior Physician

Stephanie Rassam, MD

Role: STUDY_DIRECTOR

Resident Physician

Klaus Linni, MD, PD, FEBVS

Role: PRINCIPAL_INVESTIGATOR

Head of Division

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Salzburg, Paracelsus Medical University

Salzburg, , Austria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stephanie Rassam, MD

Role: CONTACT

[email protected]
+43 572550 57506

Stephan Koter, MD, PD

Role: CONTACT

[email protected]
+43 572550 55677

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Klaus Linni, MD PD

Role: primary

[email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1144/2022

Identifier Type: -

Identifier Source: org_study_id