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

NCT00845585 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-07-17

No results posted yet for this study

Summary

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

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DEVICE

Below Knee Arterial Reconstruction

Patency, Reinterventions, Amputations, mortality

DEVICE

Below Knee Arterial Reconstruction

Patency, Reinterventions, Amputations, mortality

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Jürg Schmiedli, MD · Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845585 on ClinicalTrials.gov