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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460291
Recruitment Status : Unknown
Verified October 2007 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : April 13, 2007
Last Update Posted : October 3, 2007
B. Braun Melsungen AG
Information provided by:
Johann Wolfgang Goethe University Hospital

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 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Bypass Surgery Bypass From Autologous Varicose Vein External Graft Support Device: Implantation of the ProVena vein graft during bypass surgery Not Applicable

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. 2004), but they are not considered to be suitable if they are varicose.

Some early data indicate that these veins can be used if an external support is applied (Moritz et al. 1993, 1992, Neufang et al. 2003). The proVena vein graft has been tested in animal experiments. All bypasses showed a reduced intima hyperplasia, no disadvantages were found. Nevertheless, as a ProVena-coated bypass cannot be regarded as completely autologus, it is necessary whether the coating does not increase the risk of

  • infections
  • scar formation, reducing the patency
  • higher incidence of seroma

ProVena is made from polyester filaments, similar to the material used for prosthetic grafts. As the material is used since years in peripheral bypass surgery, we do not expect increased risks.

It is planned to include 50 Patients in 10 centres. Patients can be included if they match the eligibility criteria, need to undergo peripheral bypass surgery and have varicose veins normally not suitable to form a bypass graft. If patients agree to take part and give informed consent, baseline data are collected and the surgery is protocolled. Patients are followed up after 3 ands six months by duplex sonography. The inflammation parameters are detected via analysis of a blood sample. Main endpoints and secondary endpoints are as follows:

Main endpoints:

  • Infection rate
  • primary patency
  • primary assisted patency
  • secondary patency

Secondary endpoints:

  • complication rate
  • occurence of bypass stenosis
  • time needed for preparation of the bypass vein
  • technical success i. e. successful implatation of the ProVena Graft

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Study Start Date : June 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Primary Outcome Measures :
  1. infection rate
  2. primary patency
  3. primary assisted patency
  4. secondary patency

Secondary Outcome Measures :
  1. occurrence of complications
  2. occurence of stenoses
  3. time needed for preparation of the bypass vein
  4. technical success

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460291

Contact: Thomas Schmitz-Rixen, MD, PhD +496963015349
Contact: Matthias Tenholt, MD +496963015349

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Contact: Antje Kasper, MD    +4930450622213   
Principal Investigator: Antje Kasper, MD         
Cologne University Hospital Recruiting
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Contact: Jan Brunkwall, MD, Professor    +492214780   
Contact: Viktor Reichert, MD    +492214780   
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Kath. Kliniken Essen-Nord Recruiting
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Contact: Georg Omlor, MD, Professor    +4920164001751   
Contact: Thomas Witte, MD    +4920164001751   
Principal Investigator: Georg Omlor, MD, Professor         
Frankfurt University Hospital Recruiting
Frankfurt/Main, Germany, 60590
Contact: Thomas Schmitz-Rixen, MD, Professor    +496963015349   
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor         
Nordwestkrankenhaus Frankfurt Recruiting
Frankfurt, Germany, 60488
Contact: Max Zegelman, MD, Professor    +496976013235   
Contact: Gisela Günther    +496976014128   
Principal Investigator: Max Zegelman, MD, Professor         
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Contact: Martin Storck, MD, Professor    +497219742301   
Principal Investigator: Martin Storck, MD, Professor         
Frankenwaldklinik Kronach gGmbH Recruiting
Kronach, Germany, 96317
Contact: Ralf Peretzke, MD    +499261597460   
Contact: Gerald Hahn, MD    +499261597460   
Principal Investigator: Gerald Hahn, MD         
Mainz University Hospital Recruiting
Mainz, Germany, 55101
Contact: Walther Schmiedt, MD, Professor    +496131177079   
Contact: Achim Neufang, MD    +496131177079   
Principal Investigator: Achim Neufang, MD         
Municipal Hospital Recruiting
Muehldorf, Germany, 84453
Contact: Caspar Thierfelder, MD    +4986316130   
Principal Investigator: Caspar Thierfelder, MD         
St. Franziskus Hospital Recruiting
Muenster, Germany, 48145
Contact: Joerg Tessarek, MD    +492519353933   
Principal Investigator: Joerg Tessarek, MD         
Verbundkrankenhaus Bernkastel/Wittlich Recruiting
Wittlich, Germany, 54516
Contact: Paul Walther, MD, Professor    +496571151161   
Principal Investigator: Paul Walther, MD, Professor         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
B. Braun Melsungen AG
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospital