Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
End-stage Renal Disease
Kidney Failure, Chronic
Device: HAVG graft implantation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease|
- HAVG safety & tolerability [ Time Frame: At each visit within first 6 months after HAVG implantation. ] [ Designated as safety issue: Yes ]The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be tabulated by visit and overall.
- HAVG patency rate [ Time Frame: At 6 months after HAVG implantation. ] [ Designated as safety issue: No ]Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG.
- PRA response [ Time Frame: At screening, day 15, 29, 57 and week 12, 26 ] [ Designated as safety issue: Yes ]Assess changes in the PRA response over the 6 months after graft implantation.
- IgG antibodies [ Time Frame: At screening, day 15, 29, 57 and week 12, 26 ] [ Designated as safety issue: Yes ]Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.
- Patency maintenance/restoration [ Time Frame: At each visit except screening. ] [ Designated as safety issue: No ]Determine the rates of interventions needed to maintain / restore patency in the graft.
- HAVG patency rates [ Time Frame: At 12, 18, 24 months after HAVG implantation. ] [ Designated as safety issue: No ]Patency rates (primary, primary assisted and secondary) at 12, 18 and 24 months.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: HAVG graft
HAVG graft implantation to study participants.
Device: HAVG graft implantation
Patients will be implanted with a Human Acellular Vascular Graft (HAVG) in the forearm or upper arm (arterial anastomosis to the radial or brachial artery, venous anastomosis to either the brachial, cephalic or very central basilica vein) using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration in the first 10 patients. Loop grafts may be permitted in subsequent patients subject to acceptable graft performance at the interim safety review. Placing the graft across the elbow will be avoided.
Other Name: Human Acellular Vascular Graft
The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744418
|Department of Vascular Surgery and Angiology at the Medical University Lublin|
|Lublin, Poland, 20-081|
|Independent Public Central Clinical Hospital in Warsaw; Department of General, Vascular and Transplant Surgery|
|Warsaw, Poland, 02-097|
|Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery|
|Wroclaw, Poland, 51-124|
|Study Director:||Alison J. Pilgrim, BM BCh Phil||Humacyte, Inc.|