Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 22
- Primary Endpoint
- infection rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
infection rate
primary patency
primary assisted patency
secondary patency
Secondary Outcomes
- occurrence of complications
- occurence of stenoses
- time needed for preparation of the bypass vein
- technical success