Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460291
Status:
UNKNOWN
Last Update Posted:
2007-10-03
First Post:
2007-04-12
Brief Title:
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVENA
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None