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

April 12, 2007
October 2, 2007
June 2005
Not Provided
  • infection rate
  • primary patency
  • primary assisted patency
  • secondary patency
Same as current
Complete list of historical versions of study NCT00460291 on ClinicalTrials.gov Archive Site
  • occurrence of complications
  • occurence of stenoses
  • time needed for preparation of the bypass vein
  • technical success
Same as current
Not Provided
Not Provided
 
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
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.

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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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 Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2008
Not Provided

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
Both
18 Years and older
No
Contact: Thomas Schmitz-Rixen, MD, PhD +496963015349 schmitz-rixen@em.uni-frankfurt.de
Contact: Matthias Tenholt, MD +496963015349 Matthias.Tenholt@kgu.de
Germany
 
NCT00460291
ProVena
No
Not Provided
Johann Wolfgang Goethe University Hospitals
B. Braun Melsungen AG
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP