Clinical Trial Details

NCT ID: NCT00460291
Date Last Changed: October 2, 2007


Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein or External Graft Support

Research Study Title

Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins


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 normally are judged not to be suitable as bypass. The ProVena vein support, made from polyester, is considered to strengthen varicose veins so that they they become suitable as bypass. Thereby, the advantages of an autologous bypass and the stability of polyester material can be combined.

Patients that take part in the trial recieve an autologus bypass with a varicose vein, coated with ProVena. They are followed up at 3 and 6 months after implantation of a ProVena-coated bypass via duplex-sonography to assess the graft patency.

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Recruitment Details

Both Male and Female
18 and up
Overall Status
Lead Sponsor
Johann Wolfgang Goethe University Hospitals
Facility Type


Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • 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 Criteria:

  • 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

Site Locations (11)

Country State City Zip Facility and Contact
Germany Berlin 10117 Charité
Antje Kasper, MD

Antje Kasper, MD
Principal Investigator
Germany Cologne 50924 Cologne University Hospital
Jan Brunkwall, MD, Professor

Jan Brunkwall, MD, Professor
Principal Investigator
Germany Essen 45329 Kath. Kliniken Essen-Nord
Georg Omlor, MD, Professor

Georg Omlor, MD, Professor
Principal Investigator
Germany Frankfurt/Main 60590 Frankfurt University Hospital
Thomas Schmitz-Rixen, MD, Professor

Thomas Schmitz-Rixen, MD, Professor
Principal Investigator
Germany Frankfurt 60488 Nordwestkrankenhaus Frankfurt
Max Zegelman, MD, Professor

Max Zegelman, MD, Professor
Principal Investigator
Germany Karlsruhe 76133 Municipal Hospital Karlsruhe
Martin Storck, MD, Professor

Martin Storck, MD, Professor
Principal Investigator
Germany Kronach 96317 Frankenwaldklinik Kronach gGmbH
Ralf Peretzke, MD

Gerald Hahn, MD
Principal Investigator
Germany Mainz 55101 Mainz University Hospital
Walther Schmiedt, MD, Professor

Achim Neufang, MD
Principal Investigator
Germany Muehldorf 84453 Municipal Hospital
Caspar Thierfelder, MD

Caspar Thierfelder, MD
Principal Investigator
Germany Muenster 48145 St. Franziskus Hospital
Joerg Tessarek, MD

Joerg Tessarek, MD
Principal Investigator
Germany Wittlich 54516 Verbundkrankenhaus Bernkastel/Wittlich
Paul Walther, MD, Professor

Paul Walther, MD, Professor
Principal Investigator


Thomas Schmitz-Rixen, MD, PhD

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