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
Overview
- Phase
- N/A
- Intervention
- HAV implantation
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Humacyte, Inc.
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Change in frequency and severity of Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vessel (HAV).
The HAV 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.
Detailed Description
The HAV 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with symptomatic peripheral arterial disease who require above knee femoro-popliteal bypass surgery
- •Claudication distance of 200 m or less or rest pain or critical limb ischemia
- •Preoperative angiography or angio-CT shows superficial femoral artery occlusion of \>10 cm AND graft length required ≤ 30 cm. This imaging may have been conducted up to 3 months prior to study entry provided that the patient's symptoms have remained stable since that time
- •Preoperative imaging shows at least two below knee vessels patent to the ankle with good runoff
- •Femoral artery occlusion is not considered suitable for endovascular treatment
- •Autologous vein grafts are not suitable or feasible e.g. because of severe venous disease or prior use of leg veins for other bypass surgery or there is a clinical need to preserve those veins for future bypass surgery in the coronary or peripheral circulation
- •Aged 18 to 80 years old, inclusive
- •Hemoglobin ≥ 10 g/dL and platelet count ≥ 100,000/mm3 prior to Day 1
- •Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia prior to Day 1
- •Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; GGT, AST, ALT, and alkaline phosphatase ≤ 2x upper limit of normal or INR ≤ 1.5 prior to Day
Exclusion Criteria
- •History or evidence of severe cardiac disease (NYHA Functional Class III or IV), myocardial infarction within six months prior to study entry (Day 1), ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
- •Acute injury or active infection (including positive cultures of pathogenic bacteria) in the limb receiving the graft
- •Stroke within six (6) months prior to study entry (Day 1)
- •Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- •Women of child bearing potential
- •Active diagnosis of cancer within the previous year
- •Immunodeficiency including AIDS / HIV
- •Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- •Bleeding diathesis
- •Ongoing treatment with vitamin K antagonists or direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban)
Arms & Interventions
Human Acellular Vessel (HAV)
HAV implantation to study participants.
Intervention: HAV implantation
Outcomes
Primary Outcomes
Change in frequency and severity of Adverse Events
Time Frame: From day 1 to month 24 after HAV 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 HAV implantation.
Change from baseline in hematology, coagulation and clinical chemistry parameters.
Change in HAV characteristics
Time Frame: From day 5 to month 24 after HAV 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 HAV patency rate
Time Frame: From day 5 to month 24 after HAV implantation.
Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAV by Doppler ultrasound.
Secondary Outcomes
- Change from baseline in Panel Reactive Antibody (PRA)(From baseline to week 26 after HAV implantation.)
- Development of IgG antibodies(From baseline to week 26 after HAV implantation.)
- Graft interventions(At days 5, 15, weeks 6, 12, 16, months 12, 18, 24 after HAV implantation.)
- Effect of graft implantation on PAD symptoms(From baseline to weeks 6, 12, 26, months 12, 18, 24 after HAV implantation.)
- HAV patency rates(At months 6, 12, 18 after HAV implantation.)
- Effect of graft on ankle-brachial index (ABI)(From baseline to weeks 6, 12, 26, months 12, 18, 24 after HAV implantation.)