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

NCT00460291 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-10-03

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Bypass Surgery
  • Bypass From Autologous Varicose Vein
  • External Graft Support

Interventions

DEVICE

Implantation of the ProVena vein graft during bypass surgery

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Thomas Schmitz-Rixen, MD, Professor · Johann Wolfgang Goethe University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2008-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00460291 on ClinicalTrials.gov