Status:
WITHDRAWN
Ovine Graft (Omniflow II) Versus PTFE in Below Knee Arterial Reconstruction
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00845585
Start Date
January 1 2009
End Date
January 1 2015
Last Update
July 17 2015
Active Locations (1)
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1
Dept. of Cardiovascular Surgery
Bern, Switzerland, 3010