Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction

July 16, 2015 updated by: University Hospital Inselspital, Berne

Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction: A Prospective Randomized Multi Centre Study

The study intends to compare commonly used PTFE grafts with the biologic ovine graft Ominiflow II for below-knee bypass surgery in patients with peripheral artery occlusive disease with no autologous vein graft available. The hypothesis of this randomized trial is that that Omniflow II does not have a higher patency than PTFE over 36 months (one-sided test). An interim analysis will be performed at 18

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Background

Despite advances in endovascular therapies, arterial bypass to restore blood flow to a patent distal artery often is the best option in the management of lower extremity occlusive arterial disease. The greater saphenous vein is the conduit of choice for infrainguinal reconstructions - but it is not always available or is otherwise unusable in a significant percentage of patients. In those situations, arterial reconstruction using prosthetic material is an option. Synthetic and biological vascular grafts have been used for some three decades. With time, synthetic conduits tend to increase their thrombogenic potential rather than diminish it by formation of neointima. Over time biological grafts have become alternatives to synthetic materials, mainly in the more demanding applications below the knee. For various reasons most biological grafts have been withdrawn from the market and Omniflow II (Bio Nova International, Mel-bourne, Australia) is currently the only biological vascular prosthesis available for peripheral revascularisation.

Objective

The Omniflow II prosthesis is a biosynthetic device formed from stabilised sheep collagen with an integral polyester mesh. It is produced by inserting polyester mesh-covered mandrels beneath the cutaneous trunci muscle of adult sheep for a period of 12-14 weeks. The collagen-encapsulated tubes are harvested and stabilised using glutaraldehyde. The design provides long-term structural stability of the prosthesis and compliance that is similar to that of an autologous artery. There are no randomised studies comparing the Omniflow II graft to either autologous vein or PTFE. Extensive in vivo testing has been performed for safety and efficacy. The Omniflow graft is registered in Europe, Australia, Canada and in a range of countries in South America and South East Asia.

Methods

All patients between the ages 20 to 90 with peripheral arterial disease with severe, life-style limiting claudication, rest pain or tissue lesions based on occlusion of the femoral or popliteal artery can be considered, if no suitable vein is available for the reconstruction in infrapopliteal reconstructions. Written consent is obtained from all volunteering patients including willingness to participate in the follow-up process. Primary end point of the study is primary patency, defined by duplex scan as freedom from binary restenosis of 50%.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dept. of Cardiovascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20 to 90
  • Peripheral arterial occlusive disease with life-style limitation, claudication, rest pain, tissue loss,
  • No suitable vein for reconstruction available
  • Written consent obtained

Exclusion Criteria

  • Acute limb threatening ischaemia
  • Patient younger than 20
  • Pregnant women
  • Myocardial infarction during past 30 days
  • Stroke
  • Life expectancy < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Owniflow II
Device: Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality
ACTIVE_COMPARATOR: PTFE
Device: Below Knee Arterial Reconstruction
Patency, Reinterventions, Amputations, mortality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
primary patency, defined by duplex scan as freedom from binary restenosis of 50%
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 12 months
12 months
secondary patency
Time Frame: 3 months
3 months
limb salvage
Time Frame: 6 months
6 months
infections
Time Frame: 18 months
18 months
reinterventions
Time Frame: 24 and 36 months
24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Jürg Schmiedli, MD, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2015

Study Completion (ANTICIPATED)

January 1, 2015

Study Registration Dates

First Submitted

February 16, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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