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

Study Description

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Brief 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.

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

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

Study Design

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. infection rate
2. primary patency
3. primary assisted patency
4. secondary patency

Secondary Outcome Measures :

1. occurrence of complications
2. occurence of stenoses
3. time needed for preparation of the bypass vein
4. technical success

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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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
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

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

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Publications:

Klinkert P, Post PN, Breslau PJ, van Bockel JH. Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):357-62. Review.

Moritz A, Grabenwöger F, Raderer F, Ptakovsky H, Magometschnigg H, Ullrich R, Staudacher M. Use of varicose veins as arterial bypass grafts. Cardiovasc Surg. 1993 Oct;1(5):508-12.

Moritz A, Grabenwöger F, Raderer F, Ptakovsky H, Staudacher M, Magometschnigg H, Ullrich R, Wolner E. Mesh tube--constricted varicose veins used as bypass grafts for infrainguinal arterial reconstruction. Arch Surg. 1992 Apr;127(4):416-20.

Neufang A, Dorweiler B, Espinola-Klein C, Reinstadler J, Kirsch D, Schmiedt W, Oelert H. External reinforcement of varicose veins with PTFE prosthesis in infrainguinal bypass surgery -- clinical results. Thorac Cardiovasc Surg. 2003 Apr;51(2):62-6.

ClinicalTrials.gov Identifier:	NCT00460291 History of Changes
Other Study ID Numbers:	ProVena
First Posted:	April 13, 2007
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