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

Peripheral Arterial Disease Clinical Trial

— PROVENA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00460291
• Other study ID #: ProVena
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2007
• Last updated: October 2, 2007
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: October 2007
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Thomas Schmitz-Rixen, MD, PhD
• Phone: +496963015349
• Email: schmitz-rixen[@]em.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bypass From Autologous Varicose Vein
• External Graft Support
• Peripheral Arterial Disease
• Peripheral Bypass Surgery
• Peripheral Vascular Diseases
• Varicose Veins

Intervention

Device:
• Implantation of the ProVena vein graft during bypass surgery

Locations

Country	Name	City	State
Germany	Charité	Berlin
Germany	Cologne University Hospital	Cologne
Germany	Kath. Kliniken Essen-Nord	Essen
Germany	Nordwestkrankenhaus Frankfurt	Frankfurt
Germany	Frankfurt University Hospital	Frankfurt/Main
Germany	Municipal Hospital Karlsruhe	Karlsruhe
Germany	Frankenwaldklinik Kronach gGmbH	Kronach
Germany	Mainz University Hospital	Mainz
Germany	Municipal Hospital	Muehldorf
Germany	St. Franziskus Hospital	Muenster
Germany	Verbundkrankenhaus Bernkastel/Wittlich	Wittlich

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals	B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection rate
Primary	primary patency
Primary	primary assisted patency
Primary	secondary patency
Secondary	occurrence of complications
Secondary	occurence of stenoses
Secondary	time needed for preparation of the bypass vein
Secondary	technical success