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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease; Peripheral Bypass Surgery; Bypass From Autologous Varicose Vein; External Graft Support
• Intervention / Treatment: Device: Implantation of the ProVena vein graft during bypass surgery

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Schmitz-Rixen, MD, PhD; Phone Number: +496963015349; Email: schmitz-rixen@em.uni-frankfurt.de
• Study Contact Backup: Name: Matthias Tenholt, MD; Phone Number: +496963015349; Email: Matthias.Tenholt@kgu.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité
    • Contact: Antje Kasper, MD; Phone Number: +4930450622213; Email: antje.kasper@charite.de
    • Principal Investigator: Antje Kasper, MD
  • Cologne, Germany, 50924
    • Recruiting
    • Cologne University Hospital
    • Contact: Jan Brunkwall, MD, Professor; Phone Number: +492214780; Email: jan.brunkwall@uk-koeln.de
    • Contact: Viktor Reichert, MD; Phone Number: +492214780; Email: Viktor.Reichert@uk-koeln.de
    • Principal Investigator: Jan Brunkwall, MD, Professor
  • Essen, Germany, 45329
    • Recruiting
    • Kath. Kliniken Essen-Nord
    • Contact: Georg Omlor, MD, Professor; Phone Number: +4920164001751; Email: allvisz@kken.de
    • Contact: Thomas Witte, MD; Phone Number: +4920164001751; Email: allvisz@kken.de
    • Principal Investigator: Georg Omlor, MD, Professor
  • Frankfurt, Germany, 60488
    • Recruiting
    • Nordwestkrankenhaus Frankfurt
    • Contact: Max Zegelman, MD, Professor; Phone Number: +496976013235; Email: zegelman@t-online.de
    • Contact: Gisela Günther; Phone Number: +496976014128; Email: guenther.gisela@khnw.de
    • Principal Investigator: Max Zegelman, MD, Professor
  • Frankfurt/Main, Germany, 60590
    • Recruiting
    • Frankfurt University Hospital
    • Contact: Thomas Schmitz-Rixen, MD, Professor; Phone Number: +496963015349; Email: schmitz-rixen@em.uni-frankfurt.de
    • Principal Investigator: Thomas Schmitz-Rixen, MD, Professor
  • Karlsruhe, Germany, 76133
    • Recruiting
    • Municipal Hospital Karlsruhe
    • Contact: Martin Storck, MD, Professor; Phone Number: +497219742301; Email: Martin.Storck@Klinikum-Karlsruhe.com
    • Principal Investigator: Martin Storck, MD, Professor
  • Kronach, Germany, 96317
    • Recruiting
    • Frankenwaldklinik Kronach gGmbH
    • Contact: Ralf Peretzke, MD; Phone Number: +499261597460; Email: ralf.peretzke@frankenwaldklinik.de
    • Contact: Gerald Hahn, MD; Phone Number: +499261597460; Email: gerald.hahn@frankenwaldklinik.de
    • Principal Investigator: Gerald Hahn, MD
  • Mainz, Germany, 55101
    • Recruiting
    • Mainz University Hospital
    • Contact: Walther Schmiedt, MD, Professor; Phone Number: +496131177079; Email: schmiedt@mail.uni-mainz.de
    • Contact: Achim Neufang, MD; Phone Number: +496131177079; Email: neufang@mail.uni-mainz.de
    • Principal Investigator: Achim Neufang, MD
  • Muehldorf, Germany, 84453
    • Recruiting
    • Municipal Hospital
    • Contact: Caspar Thierfelder, MD; Phone Number: +4986316130; Email: caspar.thierfelder@kh-muehldorf.de
    • Principal Investigator: Caspar Thierfelder, MD
  • Muenster, Germany, 48145
    • Recruiting
    • St. Franziskus Hospital
    • Contact: Joerg Tessarek, MD; Phone Number: +492519353933; Email: Joerg.Tessarek@SFH-MUENSTER.de
    • Principal Investigator: Joerg Tessarek, MD
  • Wittlich, Germany, 54516
    • Recruiting
    • Verbundkrankenhaus Bernkastel/Wittlich
    • Contact: Paul Walther, MD, Professor; Phone Number: +496571151161; Email: gefaesschirurgie@verbund-krankenhaus.de
    • Principal Investigator: Paul Walther, MD, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
infection rate
primary patency
primary assisted patency
secondary patency

Secondary Outcome Measures

Outcome Measure
occurrence of complications
occurence of stenoses
time needed for preparation of the bypass vein
technical success

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: B. Braun Melsungen AG
• Investigators: Principal Investigator: Thomas Schmitz-Rixen, MD, Professor, Johann Wolfgang Goethe University Hospital

Publications and helpful links

General 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. doi: 10.1016/j.ejvs.2003.12.027.
• Moritz A, Grabenwoger 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, Grabenwoger 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. doi: 10.1001/archsurg.1992.01420040058010.
• 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. doi: 10.1055/s-2003-38985.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion: December 7, 2022
• Study Completion (Anticipated): December 1, 2008

Study Registration Dates

• First Submitted: April 12, 2007
• First Submitted That Met QC Criteria: April 12, 2007
• First Posted (Estimate): April 13, 2007

Study Record Updates

• Last Update Posted (Estimate): October 3, 2007
• Last Update Submitted That Met QC Criteria: October 2, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: PAD; vein bypass; supported varicose veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Varicose Veins
• Other Study ID Numbers: ProVena

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No