Clinical Trial Details

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

Overview

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

Purpose

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.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Johann Wolfgang Goethe University Hospitals
Duration
Facility Type
N/A
Compensation

Eligibility

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
+4930450622213
antje.kasper@charite.de

Antje Kasper, MD
Principal Investigator
Germany Cologne 50924 Cologne University Hospital
Jan Brunkwall, MD, Professor
+492214780
jan.brunkwall@uk-koeln.de

Jan Brunkwall, MD, Professor
Principal Investigator
Germany Essen 45329 Kath. Kliniken Essen-Nord
Georg Omlor, MD, Professor
+4920164001751
allvisz@kken.de

Georg Omlor, MD, Professor
Principal Investigator
Germany Frankfurt/Main 60590 Frankfurt University Hospital
Thomas Schmitz-Rixen, MD, Professor
+496963015349
schmitz-rixen@em.uni-frankfurt.de

Thomas Schmitz-Rixen, MD, Professor
Principal Investigator
Germany Frankfurt 60488 Nordwestkrankenhaus Frankfurt
Max Zegelman, MD, Professor
+496976013235
zegelman@t-online.de

Max Zegelman, MD, Professor
Principal Investigator
Germany Karlsruhe 76133 Municipal Hospital Karlsruhe
Martin Storck, MD, Professor
+497219742301
Martin.Storck@Klinikum-Karlsruhe.com

Martin Storck, MD, Professor
Principal Investigator
Germany Kronach 96317 Frankenwaldklinik Kronach gGmbH
Ralf Peretzke, MD
+499261597460
ralf.peretzke@frankenwaldklinik.de

Gerald Hahn, MD
Principal Investigator
Germany Mainz 55101 Mainz University Hospital
Walther Schmiedt, MD, Professor
+496131177079
schmiedt@mail.uni-mainz.de

Achim Neufang, MD
Principal Investigator
Germany Muehldorf 84453 Municipal Hospital
Caspar Thierfelder, MD
+4986316130
caspar.thierfelder@kh-muehldorf.de

Caspar Thierfelder, MD
Principal Investigator
Germany Muenster 48145 St. Franziskus Hospital
Joerg Tessarek, MD
+492519353933
Joerg.Tessarek@SFH-MUENSTER.de

Joerg Tessarek, MD
Principal Investigator
Germany Wittlich 54516 Verbundkrankenhaus Bernkastel/Wittlich
Paul Walther, MD, Professor
+496571151161
gefaesschirurgie@verbund-krankenhaus.de

Paul Walther, MD, Professor
Principal Investigator

Contact

Thomas Schmitz-Rixen, MD, PhD
+496963015349
E-mail:

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