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

Primary Purpose

Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implantation of the ProVena vein graft during bypass surgery
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring PAD, vein bypass, supported varicose veins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CharitéRecruiting
  • Cologne University HospitalRecruiting
  • Kath. Kliniken Essen-NordRecruiting
  • Frankfurt University HospitalRecruiting
  • Nordwestkrankenhaus FrankfurtRecruiting
  • Municipal Hospital KarlsruheRecruiting
  • Frankenwaldklinik Kronach gGmbHRecruiting
  • Mainz University HospitalRecruiting
  • Municipal HospitalRecruiting
  • St. Franziskus HospitalRecruiting
  • Verbundkrankenhaus Bernkastel/WittlichRecruiting

Outcomes

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

Full Information

First Posted
April 12, 2007
Last Updated
October 2, 2007
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
B. Braun Melsungen AG
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1. Study Identification

Unique Protocol Identification Number
NCT00460291
Brief Title
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Acronym
PROVENA
Official Title
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein, External Graft Support
Keywords
PAD, vein bypass, supported varicose veins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Implantation of the ProVena vein graft during bypass surgery
Primary Outcome Measure Information:
Title
infection rate
Title
primary patency
Title
primary assisted patency
Title
secondary patency
Secondary Outcome Measure Information:
Title
occurrence of complications
Title
occurence of stenoses
Title
time needed for preparation of the bypass vein
Title
technical success

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Schmitz-Rixen, MD, PhD
Phone
+496963015349
Email
schmitz-rixen@em.uni-frankfurt.de
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Tenholt, MD
Phone
+496963015349
Email
Matthias.Tenholt@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz-Rixen, MD, Professor
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antje Kasper, MD
Phone
+4930450622213
Email
antje.kasper@charite.de
First Name & Middle Initial & Last Name & Degree
Antje Kasper, MD
Facility Name
Cologne University Hospital
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Brunkwall, MD, Professor
Phone
+492214780
Email
jan.brunkwall@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Viktor Reichert, MD
Phone
+492214780
Email
Viktor.Reichert@uk-koeln.de
First Name & Middle Initial & Last Name & Degree
Jan Brunkwall, MD, Professor
Facility Name
Kath. Kliniken Essen-Nord
City
Essen
ZIP/Postal Code
45329
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Omlor, MD, Professor
Phone
+4920164001751
Email
allvisz@kken.de
First Name & Middle Initial & Last Name & Degree
Thomas Witte, MD
Phone
+4920164001751
Email
allvisz@kken.de
First Name & Middle Initial & Last Name & Degree
Georg Omlor, MD, Professor
Facility Name
Frankfurt University Hospital
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz-Rixen, MD, Professor
Phone
+496963015349
Email
schmitz-rixen@em.uni-frankfurt.de
First Name & Middle Initial & Last Name & Degree
Thomas Schmitz-Rixen, MD, Professor
Facility Name
Nordwestkrankenhaus Frankfurt
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Zegelman, MD, Professor
Phone
+496976013235
Email
zegelman@t-online.de
First Name & Middle Initial & Last Name & Degree
Gisela Günther
Phone
+496976014128
Email
guenther.gisela@khnw.de
First Name & Middle Initial & Last Name & Degree
Max Zegelman, MD, Professor
Facility Name
Municipal Hospital Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Storck, MD, Professor
Phone
+497219742301
Email
Martin.Storck@Klinikum-Karlsruhe.com
First Name & Middle Initial & Last Name & Degree
Martin Storck, MD, Professor
Facility Name
Frankenwaldklinik Kronach gGmbH
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Peretzke, MD
Phone
+499261597460
Email
ralf.peretzke@frankenwaldklinik.de
First Name & Middle Initial & Last Name & Degree
Gerald Hahn, MD
Phone
+499261597460
Email
gerald.hahn@frankenwaldklinik.de
First Name & Middle Initial & Last Name & Degree
Gerald Hahn, MD
Facility Name
Mainz University Hospital
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walther Schmiedt, MD, Professor
Phone
+496131177079
Email
schmiedt@mail.uni-mainz.de
First Name & Middle Initial & Last Name & Degree
Achim Neufang, MD
Phone
+496131177079
Email
neufang@mail.uni-mainz.de
First Name & Middle Initial & Last Name & Degree
Achim Neufang, MD
Facility Name
Municipal Hospital
City
Muehldorf
ZIP/Postal Code
84453
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caspar Thierfelder, MD
Phone
+4986316130
Email
caspar.thierfelder@kh-muehldorf.de
First Name & Middle Initial & Last Name & Degree
Caspar Thierfelder, MD
Facility Name
St. Franziskus Hospital
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Tessarek, MD
Phone
+492519353933
Email
Joerg.Tessarek@SFH-MUENSTER.de
First Name & Middle Initial & Last Name & Degree
Joerg Tessarek, MD
Facility Name
Verbundkrankenhaus Bernkastel/Wittlich
City
Wittlich
ZIP/Postal Code
54516
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Walther, MD, Professor
Phone
+496571151161
Email
gefaesschirurgie@verbund-krankenhaus.de
First Name & Middle Initial & Last Name & Degree
Paul Walther, MD, Professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
15015183
Citation
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.
Results Reference
background
PubMed Identifier
8076087
Citation
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.
Results Reference
background
PubMed Identifier
1558494
Citation
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.
Results Reference
background
PubMed Identifier
12730812
Citation
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.
Results Reference
background

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

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