Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02887859 |
Recruitment Status :
Active, not recruiting
First Posted : September 2, 2016
Last Update Posted : December 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Artery Disease | Biological: Human Acellular Vessel (HAV) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Use as a Vascular Prosthesis for Femoro-Popliteal Bypass in Patients With Peripheral Arterial Disease |
Actual Study Start Date : | December 20, 2016 |
Actual Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: HAV Treatment
Human Acellular Vessel (HAV)
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Biological: Human Acellular Vessel (HAV)
Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques |
- Incidence of aneurysm formation, anastomotic bleeding or rupture, HAV infection, HAV removal and irritation/inflammation at the HAV implantation site [ Time Frame: 12 months ]
- Frequency and severity of adverse events [ Time Frame: 12 months ]
- HAV Patency Rates (Primary, Primary-assisted, Secondary) - see Description [ Time Frame: 12 months ]Primary patency = patent ("open" to blood flow) without any interventions; Primary-assisted patency = patent without an intervention to clear a thrombus; Secondary patency = patent with or without interventions
- Hemodynamically significant stenosis (>70% by duplex ultrasound criteria) [ Time Frame: 12 months ]
- Change in PRA from baseline [ Time Frame: 12 months ]
- Changes from baseline in hematology parameters [ Time Frame: 12 months ]
- Changes from baseline in coagulation parameters [ Time Frame: 12 months ]
- Changes from baseline in clinical chemistry parameters [ Time Frame: 12 months ]
- Rate of HAV interventions [ Time Frame: 12 months ]e.g., angioplasty, thrombectomy, surgical revision
- Patient reported PAD symptoms (VascuQol) [ Time Frame: 12 months ]
- Ankle brachial index (ABI) [ Time Frame: 12 months ]
- Six minute walk test [ Time Frame: 12 months ]
- Microscopic evidence of HAV remodeling (host cells within HAV) [ Time Frame: 12 months ]
- Patient survival [ Time Frame: 60 months ]
- Frequency of HAV remaining as a functional conduit in situ (with or without interventions) [ Time Frame: 60 months ]
- Evidence of aneurysmal dilatation (conduit lumen diameter >9 mm) or stenosis of the HAV (>70%) on routine clinical US [ Time Frame: 60 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patients with disabling symptomatic peripheral arterial disease
- Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
- Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
- Ankle - brachial index ≤ 0.6 in the study leg
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Patient has failed adequate medical therapy which included
- Exercise program
- Smoking cessation therapy
- Control of diabetes, hypertension and dyslipidemias
- Antiplatelet therapy
- Preoperative angiography or CT angiography shows superficial femoral artery occlusion AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 38cm. This imaging may have been conducted up to 6 months prior to study entry provided that the patient's symptoms have remained stable since that time
- Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff
- Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery
- Distal anastomosis is expected to be to the popliteal artery above the knee
- Femoral artery occlusion is not considered suitable for endovascular treatment; e.g. long segment chronic total occlusion, previous failed stent or stent graft in the superficial femoral artery, previous failed endovascular treatment where the lesion could not be crossed
- Autologous vein graft is not feasible in the judgment of the treating surgeon; e.g. because all suitable veins have been used previously for coronary or peripheral bypass, or pre-operative vein mapping shows inadequate length or quality of vein to complete the planned bypass
- Aged 18 to 85 years old, inclusive
- Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
- Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening
- Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; and INR ≤ 1.5 at screening
- Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
- Life expectancy of at least 1 year
Exclusion Criteria:
- Leg at high risk of amputation (SVS WIfI stage 4)
- Recent clinically significant trauma to the leg receiving the HAV
- Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
- Distal anastomosis planned to a below knee artery
- 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
- Stroke within six (6) months prior to study entry (Day 1)
- Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR<45mL/min)
- Uncontrolled diabetes (HbA1c >10% at screening)
- Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
- Cancer that is being actively treated with a cytotoxic agent
- AIDS / HIV infection
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Documented hypercoagulable state or history as defined as either:
- a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -
- a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g. DVT, PE, etc.) within the previous 5 years
- Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
- Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )
- Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative leg
- Stenosis of >50% of the inflow aortoiliac system ipsilateral to the index leg. Any such stenosis must be corrected with angioplasty with or without stenting prior to, or at the time of, HAV implantation
- Active autoimmune disease - symptomatic or requiring ongoing drug therapy
- Active local or systemic infection (WBC > 15,000/mm3)
- Known serious allergy to aspirin
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the Humacyte Human Acellular Vessel (HAV)
- Previous exposure to HAV
- Employees of the sponsor or patients who are employees or relatives of the investigator
- Pregnant women or women planning to become pregnant (Women of child bearing potential, WOCBP, must use adequate contraception [hormonal or barrier method of birth control; abstinence] for the duration of study participation; WOCBP defined as not sterile or not > 1 year postmenopausal.)

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): NCT02887859
United States, California | |
UCSF | |
San Francisco, California, United States, 94143 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Michigan Vascular Center | |
Flint, Michigan, United States, 48507 | |
United States, New Jersey | |
Overlook Medical Center | |
Summit, New Jersey, United States, 07901 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27708 |
Study Director: | Lynda Szczech, MD, MSCE | Humacyte, Inc. |
Responsible Party: | Humacyte, Inc. |
ClinicalTrials.gov Identifier: | NCT02887859 |
Other Study ID Numbers: |
CLN-PRO-V004 |
First Posted: | September 2, 2016 Key Record Dates |
Last Update Posted: | December 8, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |