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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00460291
First received: April 12, 2007
Last updated: October 2, 2007
Last verified: October 2007
  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.


Condition Intervention
Peripheral Arterial Disease
Peripheral Bypass Surgery
Bypass From Autologous Varicose Vein
External Graft Support
Device: Implantation of the ProVena vein graft during bypass surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • infection rate
  • primary patency
  • primary assisted patency
  • secondary patency

Secondary Outcome Measures:
  • occurrence of complications
  • occurence of stenoses
  • time needed for preparation of the bypass vein
  • technical success

Estimated Enrollment: 50
Study Start Date: June 2005
Estimated Study Completion Date: December 2008
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460291

Contacts
Contact: Thomas Schmitz-Rixen, MD, PhD +496963015349 schmitz-rixen@em.uni-frankfurt.de
Contact: Matthias Tenholt, MD +496963015349 Matthias.Tenholt@kgu.de

Locations
Germany
Charité Recruiting
Berlin, Germany, 10117
Contact: Antje Kasper, MD    +4930450622213    antje.kasper@charite.de   
Principal Investigator: Antje Kasper, MD         
Cologne University Hospital Recruiting
Cologne, Germany, 50924
Contact: Jan Brunkwall, MD, Professor    +492214780    jan.brunkwall@uk-koeln.de   
Contact: Viktor Reichert, MD    +492214780    Viktor.Reichert@uk-koeln.de   
Principal Investigator: Jan Brunkwall, MD, Professor         
Kath. Kliniken Essen-Nord Recruiting
Essen, Germany, 45329
Contact: Georg Omlor, MD, Professor    +4920164001751    allvisz@kken.de   
Contact: Thomas Witte, MD    +4920164001751    allvisz@kken.de   
Principal Investigator: Georg Omlor, MD, Professor         
Nordwestkrankenhaus Frankfurt Recruiting
Frankfurt, Germany, 60488
Contact: Max Zegelman, MD, Professor    +496976013235    zegelman@t-online.de   
Contact: Gisela Günther    +496976014128    guenther.gisela@khnw.de   
Principal Investigator: Max Zegelman, MD, Professor         
Frankfurt University Hospital Recruiting
Frankfurt/Main, Germany, 60590
Contact: Thomas Schmitz-Rixen, MD, Professor    +496963015349    schmitz-rixen@em.uni-frankfurt.de   
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor         
Municipal Hospital Karlsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: Martin Storck, MD, Professor    +497219742301    Martin.Storck@Klinikum-Karlsruhe.com   
Principal Investigator: Martin Storck, MD, Professor         
Frankenwaldklinik Kronach gGmbH Recruiting
Kronach, Germany, 96317
Contact: Ralf Peretzke, MD    +499261597460    ralf.peretzke@frankenwaldklinik.de   
Contact: Gerald Hahn, MD    +499261597460    gerald.hahn@frankenwaldklinik.de   
Principal Investigator: Gerald Hahn, MD         
Mainz University Hospital Recruiting
Mainz, Germany, 55101
Contact: Walther Schmiedt, MD, Professor    +496131177079    schmiedt@mail.uni-mainz.de   
Contact: Achim Neufang, MD    +496131177079    neufang@mail.uni-mainz.de   
Principal Investigator: Achim Neufang, MD         
Municipal Hospital Recruiting
Muehldorf, Germany, 84453
Contact: Caspar Thierfelder, MD    +4986316130    caspar.thierfelder@kh-muehldorf.de   
Principal Investigator: Caspar Thierfelder, MD         
St. Franziskus Hospital Recruiting
Muenster, Germany, 48145
Contact: Joerg Tessarek, MD    +492519353933    Joerg.Tessarek@SFH-MUENSTER.de   
Principal Investigator: Joerg Tessarek, MD         
Verbundkrankenhaus Bernkastel/Wittlich Recruiting
Wittlich, Germany, 54516
Contact: Paul Walther, MD, Professor    +496571151161    gefaesschirurgie@verbund-krankenhaus.de   
Principal Investigator: Paul Walther, MD, Professor         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
B. Braun Melsungen AG
Investigators
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospitals
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00460291     History of Changes
Other Study ID Numbers: ProVena
Study First Received: April 12, 2007
Last Updated: October 2, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
PAD
vein bypass
supported varicose veins

Additional relevant MeSH terms:
Varicose Veins
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 20, 2014