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

- infection rate
- primary patency
- primary assisted patency
- secondary patency
- occurrence of complications
- occurence of stenoses
- time needed for preparation of the bypass vein
- technical success

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00460291
Contact: Thomas Schmitz-Rixen, MD, PhD | +496963015349 | schmitz-rixen@em.uni-frankfurt.de | |
Contact: Matthias Tenholt, MD | +496963015349 | Matthias.Tenholt@kgu.de |
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 | |
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 | |
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 | |
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 |
Principal Investigator: | Thomas Schmitz-Rixen, MD, Professor | Johann Wolfgang Goethe University Hospital |
Publications:
ClinicalTrials.gov Identifier: | NCT00460291 History of Changes |
Other Study ID Numbers: |
ProVena |
First Posted: | April 13, 2007 Key Record Dates |
Last Update Posted: | October 3, 2007 |
Last Verified: | October 2007 |
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 |