Status:
UNKNOWN
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Peripheral Arterial Disease
Peripheral Bypass Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
If patients need to undergo bypass surgery, either an autologous vein can be used as bypass or, if there are no suitable veins are available, a prosthetic graft can be implanted. Varicose veins normal...
Detailed Description
The ProVena trial is a non-randomised multi-centre trial, aiming to assess the suitability of the ProVena vein support. Currently, autologous veins are preferred to prosthetic grafts (Klinkert et al....
Eligibility Criteria
Inclusion
- aged \> 18 years 18 Jahre.
- informed consent has been given and patients is complient to protocol
- patient needs femoro-distal bypass surgery
- only varicose ektatic veins are available
- Bypass diameter \> 5mm proximal and \> 4mm distal.
Exclusion
- aged \< 18 years
- patient unable to take part in the follow-up
- known sensibility to polyester
- patient not expected to survive the next 12 months due to significant comorbidities
- HIV-infection
- Patient suffering from a floriding infection at the time of inclusion
- infection or colonisation with MRSA
- pregnancy
- use of immunosuppresive drugs
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00460291
Start Date
June 1 2005
End Date
December 1 2008
Last Update
October 3 2007
Active Locations (11)
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1
Charité
Berlin, Germany, 10117
2
Cologne University Hospital
Cologne, Germany, 50924
3
Kath. Kliniken Essen-Nord
Essen, Germany, 45329
4
Nordwestkrankenhaus Frankfurt
Frankfurt, Germany, 60488