Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD
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|ClinicalTrials.gov Identifier: NCT01872208|
Recruitment Status : Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment|
|Peripheral Arterial Disease Peripheral Vascular Disease||Device: HAVG graft implantation|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2013|
|Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2019|
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|