FRAMED Infrainguinal Venous Bypass Versus Conventional Au... | NCT06082466

Studies
FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial

NCT06082466

Sponsor

Paracelsus Medical University

Status

Recruiting

Last Update Posted

Nov 21, 2023Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

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

Interventions

FRAMED Infrainguinal Venous Bypass
Conventional Autologous Bypass

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2023Actual

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Sep 4, 2023

First Submission Date that Met QC Criteria

Oct 9, 2023

First Posted Date

Oct 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Linni, Head of Division of Vascular and Endovascular Surgery, MD PD, Paracelsus Medical UniversityPrincipal Investigator

Lead Sponsor

Paracelsus Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Autologous Bypass	Active Comparator		Procedure: Conventional Autologous Bypass
FRAMED Infrainguinal Venous Bypass	Active Comparator		Procedure: FRAMED Infrainguinal Venous Bypass

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FRAMED Infrainguinal Venous Bypass	Procedure	The harvested vein graft will be covered with a mesh.	FRAMED Infrainguinal Venous Bypass

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephanie Rassam, MD	Contact	+43 572550 57506		s.rassam@salk.at
Stephan Koter, MD, PD	Contact	+43 572550 55677		s.koter@salk.at

Overall Officials

Name	Affiliation	Role
Stephan Koter, MD, PD	Senior Physician	Principal Investigator
Stephanie Rassam, MD	Resident Physician	Study Director
Klaus Linni, MD, PD, FEBVS

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Salzburg, Paracelsus Medical University	Recruiting	Salzburg		5020	Austria

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
C564658	Peripheral Arterial Occlusive Disease 1
D007383	Intermittent Claudication

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms