Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD
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 an above-knee femoro-popliteal bypass graft in patients with peripheral arterial disease.
|Peripheral Arterial Disease Peripheral Vascular Disease||Device: HAVG graft implantation|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte's Human Acellular Vascular Graft as an Above-Knee Femoro-Popliteal Bypass Graft in Patients With Peripheral Arterial Disease|
- Change in HAVG graft characteristics [ Time Frame: From day 5 to month 24 after HAVG implantation. ]The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.
- Change in HAVG patency rate [ Time Frame: From day 5 to month 24 after HAVG implantation. ]Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.
- Change in frequency and severity of Adverse Events [ Time Frame: From day 1 to month 24 after HAVG implantation. ]Frequency and severity of AEs of each patient will be documented.
- Change in hematology, coagulation and clinical chemistry parameters [ Time Frame: From baseline to week 26 after HAVG implantation. ]Change from baseline in hematology, coagulation and clinical chemistry parameters.
- Change from baseline in Panel Reactive Antibody (PRA) [ Time Frame: From baseline to week 26 after HAVG implantation. ]Assess changes in the Panel Reactive Antibody response over 6 months after graft implantation.
- Development of IgG antibodies [ Time Frame: From baseline to week 26 after HAVG implantation. ]Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG over the 6 months after implantation.
- HAVG patency rates [ Time Frame: At months 6, 12, 18 after HAVG implantation. ]To determine the patency rates of the graft (primary, primary assisted and secondary).
- Graft interventions [ Time Frame: At days 5, 15, weeks 6, 12, 16, months 12, 18, 24 after HAVG implantation. ]Determine the rates of interventions needed to maintain / restore patency in the graft.
- Effect of graft implantation on PAD symptoms [ Time Frame: From baseline to weeks 6, 12, 26, months 12, 18, 24 after HAVG implantation. ]Assessment of any effect of graft implantation on claudication, rest pain and ischemic ulcers.
- Effect of graft on ankle-brachial index (ABI) [ Time Frame: From baseline to weeks 6, 12, 26, months 12, 18, 24 afer HAVG implantation. ]Assessment of any effect of the graft on ankle-brachial index (ABI).
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2019|
|Primary Completion Date:||June 2016 (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) as an above-knee femoro-popliteal bypass graft using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration.
Other Name: Human Acellular Vascular Graft
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872208
|Clinic of Vascular Surgery and Angiology; Medical University in Lublin|
|Lublin, Poland, 20-081|
|Pomeranian University in Szczecin; Clinic of General, Vascular Surgery and Angiology|
|Szczecin, Poland, 70-111|
|Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery|
|Wrocław, Poland, 51-124|
|Study Director:||Alison J Pilgrim, BM MCh Phil||Humacyte, Inc.|