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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
Johann Wolfgang Goethe University Hospital
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 Hospital:

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   (Adult, Senior)
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

Locations
Germany
Charité
Berlin, Germany, 10117
Cologne University Hospital
Cologne, Germany, 50924
Kath. Kliniken Essen-Nord
Essen, Germany, 45329
Frankfurt University Hospital
Frankfurt/Main, Germany, 60590
Nordwestkrankenhaus Frankfurt
Frankfurt, Germany, 60488
Municipal Hospital Karlsruhe
Karlsruhe, Germany, 76133
Frankenwaldklinik Kronach gGmbH
Kronach, Germany, 96317
Mainz University Hospital
Mainz, Germany, 55101
Municipal Hospital
Muehldorf, Germany, 84453
St. Franziskus Hospital
Muenster, Germany, 48145
Verbundkrankenhaus Bernkastel/Wittlich
Wittlich, Germany, 54516
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
B. Braun Melsungen AG
Investigators
Principal Investigator: Thomas Schmitz-Rixen, MD, Professor Johann Wolfgang Goethe University Hospital
  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 Hospital:
PAD
vein bypass
supported varicose veins

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

ClinicalTrials.gov processed this record on December 06, 2016