Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
NCT ID: NCT00460291
Last Updated: 2007-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2005-06-30
2008-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Implantation of the ProVena vein graft during bypass surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
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Thomas Schmitz-Rixen, MD, Professor
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital
Locations
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Charité
Berlin, , Germany
Cologne University Hospital
Cologne, , Germany
Kath. Kliniken Essen-Nord
Essen, , Germany
Nordwestkrankenhaus Frankfurt
Frankfurt, , Germany
Frankfurt University Hospital
Frankfurt am Main, , Germany
Municipal Hospital Karlsruhe
Karlsruhe, , Germany
Frankenwaldklinik Kronach gGmbH
Kronach, , Germany
Mainz University Hospital
Mainz, , Germany
Municipal Hospital
Mühldorf, , Germany
St. Franziskus Hospital
Münster, , Germany
Verbundkrankenhaus Bernkastel/Wittlich
Wittlich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Antje Kasper, MD
Role: primary
Jan Brunkwall, MD, Professor
Role: primary
Viktor Reichert, MD
Role: backup
Georg Omlor, MD, Professor
Role: primary
Thomas Witte, MD
Role: backup
Max Zegelman, MD, Professor
Role: primary
Gisela Günther
Role: backup
Thomas Schmitz-Rixen, MD, Professor
Role: primary
Martin Storck, MD, Professor
Role: primary
Ralf Peretzke, MD
Role: primary
Gerald Hahn, MD
Role: backup
Walther Schmiedt, MD, Professor
Role: primary
Achim Neufang, MD
Role: backup
Caspar Thierfelder, MD
Role: primary
Joerg Tessarek, MD
Role: primary
Paul Walther, MD, Professor
Role: primary
References
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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.
Other Identifiers
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ProVena
Identifier Type: -
Identifier Source: org_study_id