Peripheral Arterial DiseasePROVENANCT00460291
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
A study testing Implantation of the ProVena vein graft during bypass surgery in people with Peripheral Arterial Disease and Peripheral Bypass Surgery, run by Johann Wolfgang Goethe University Hospital at 11 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein
- What is being tested?
- Implantation of the ProVena vein graft during bypass surgery
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 11 sitesGermany
- Study dates
- Jun 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- infection or colonisation with MRSA
- pregnancy
- use of immunosuppresive drugs
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites, 11 recruiting
- Recruiting
Charité
Berlin, 10117
Antje Kasper, MD, +4930450622213, antje.kasper@charite.de
Antje Kasper, MD
- Recruiting
Cologne University Hospital
Cologne, 50924
Jan Brunkwall, MD, Professor, +492214780, jan.brunkwall@uk-koeln.de
Viktor Reichert, MD, +492214780, Viktor.Reichert@uk-koeln.de
- Recruiting
Kath. Kliniken Essen-Nord
Essen, 45329
Georg Omlor, MD, Professor, +4920164001751, allvisz@kken.de
Thomas Witte, MD, +4920164001751, allvisz@kken.de
- Recruiting
Nordwestkrankenhaus Frankfurt
Frankfurt, 60488
Max Zegelman, MD, Professor, +496976013235, zegelman@t-online.de
Gisela Günther, +496976014128, guenther.gisela@khnw.de
- Recruiting
Frankfurt University Hospital
Frankfurt am Main, 60590
Thomas Schmitz-Rixen, MD, Professor, +496963015349, schmitz-rixen@em.uni-frankfurt.de
Thomas Schmitz-Rixen, MD, Professor
- Recruiting
Municipal Hospital Karlsruhe
Karlsruhe, 76133
Martin Storck, MD, Professor, +497219742301, Martin.Storck@Klinikum-Karlsruhe.com
Martin Storck, MD, Professor
- Recruiting
Frankenwaldklinik Kronach gGmbH
Kronach, 96317
Ralf Peretzke, MD, +499261597460, ralf.peretzke@frankenwaldklinik.de
Gerald Hahn, MD, +499261597460, gerald.hahn@frankenwaldklinik.de
- Recruiting
Mainz University Hospital
Mainz, 55101
Walther Schmiedt, MD, Professor, +496131177079, schmiedt@mail.uni-mainz.de
Achim Neufang, MD, +496131177079, neufang@mail.uni-mainz.de
- Recruiting
Municipal Hospital
Mühldorf, 84453
Caspar Thierfelder, MD, +4986316130, caspar.thierfelder@kh-muehldorf.de
Caspar Thierfelder, MD
- Recruiting
St. Franziskus Hospital
Münster, 48145
Joerg Tessarek, MD, +492519353933, Joerg.Tessarek@SFH-MUENSTER.de
Joerg Tessarek, MD
- Recruiting
Verbundkrankenhaus Bernkastel/Wittlich
Wittlich, 54516
Paul Walther, MD, Professor, +496571151161, gefaesschirurgie@verbund-krankenhaus.de
Paul Walther, MD, Professor
About this study
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.
Read the 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
- Conditions
- Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein, External Graft Support
- Being tested
- Implantation of the ProVena vein graft during bypass surgery
- Keywords
- PAD, vein bypass, supported varicose veins
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the ProVena vein graft during bypass surgeryDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
infection rate
primary patency
primary assisted patency
secondary patency
Secondary outcomes (4)
occurrence of complications
occurence of stenoses
time needed for preparation of the bypass vein
technical success
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startJun 2005
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Investigators
- Thomas Schmitz-Rixen, MD, Professor, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460291
- Sponsor's protocol ID
- ProVena
- Acronym
- PROVENA
- Status last verified
- Oct 2007
- First submitted
- 12 Apr 2007
- Last updated
- 3 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15015183Moritz 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. doi: 10.1177/096721099300100508.
PubMed 8076087Moritz 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.
PubMed 1558494Neufang 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.
PubMed 12730812
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
- ClinicalTrials.gov ID
- NCT00460291
- Acronym / sponsor ID
- PROVENA / ProVena
- Conditions
- Peripheral Arterial Disease, Peripheral Bypass Surgery, Bypass From Autologous Varicose Vein, External Graft Support
- Keywords
- PAD, vein bypass, supported varicose veins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Jun 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 13 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the ProVena vein graft during bypass surgery | Device | – |
Primary outcome
infection rate
primary patency
primary assisted patency
secondary patency
4 secondary outcomes
occurrence of complications
occurence of stenoses
time needed for preparation of the bypass vein
technical success
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2007.
- Background: PubMed 15015183Klinkert 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.
- Background: PubMed 8076087Moritz 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. doi: 10.1177/096721099300100508.
- Background: PubMed 1558494Moritz 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.
- Background: PubMed 12730812Neufang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schmitz-Rixen, MD, Professor principal investigator
Johann Wolfgang Goethe University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the ProVena vein graft during bypass surgery in people with Peripheral Arterial Disease and Peripheral Bypass Surgery, run by Johann Wolfgang Goethe University Hospital at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Schmitz-Rixen, MD, PhD (+496963015349, schmitz-rixen@em.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection rate. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460291, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2007.