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Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

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ClinicalTrials.gov Identifier: NCT02887859
Recruitment Status : Recruiting
First Posted : September 2, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Atlantic Research Group
Information provided by (Responsible Party):
Humacyte, Inc.

Brief Summary:
This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD). This study will also evaluate how safe it is to use the HAV in this manner.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Biological: Human Acellular Vessel (HAV) Phase 2

Detailed Description:
This is a prospective, open label, single treatment arm, multicenter phase 2 study to evaluate the safety and efficacy of the HAV in patients with PAD undergoing femoro-popliteal bypass surgery. The primary objective of this study is to evaluate the safety and tolerability of the HAV in these patients and to determine the patency of the Humacyte HAV at 12 months post-implantation. The secondary objectives of this study are to further assess safety in terms of PRA response, and to determine the rates of HAV interventions required to keep the HAV patent. There is no formal hypothesis testing planned; the study involves only a single, open-label treatment group.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HAV Treatment
Human Acellular Vessel (HAV)
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




Primary Outcome Measures :
  1. Incidence of aneurysm formation, anastomotic bleeding or rupture, HAV infection, HAV removal and irritation/inflammation at the HAV implantation site [ Time Frame: 12 months ]
  2. Frequency and severity of adverse events [ Time Frame: 12 months ]
  3. 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

  4. Hemodynamically significant stenosis (>70% by duplex ultrasound criteria) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in PRA from baseline [ Time Frame: 12 months ]
  2. Changes from baseline in hematology parameters [ Time Frame: 12 months ]
  3. Changes from baseline in coagulation parameters [ Time Frame: 12 months ]
  4. Changes from baseline in clinical chemistry parameters [ Time Frame: 12 months ]
  5. Rate of HAV interventions [ Time Frame: 12 months ]
    e.g., angioplasty, thrombectomy, surgical revision

  6. Patient reported PAD symptoms (VascuQol) [ Time Frame: 12 months ]
  7. Ankle brachial index (ABI) [ Time Frame: 12 months ]
  8. Six minute walk test [ Time Frame: 12 months ]
  9. Microscopic evidence of HAV remodeling (host cells within HAV) [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Patient survival [ Time Frame: 60 months ]
  2. Frequency of HAV remaining as a functional conduit in situ (with or without interventions) [ Time Frame: 60 months ]
  3. 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
Criteria

Inclusion Criteria:

  1. Patients with disabling symptomatic peripheral arterial disease

    1. Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
    2. Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
  2. Ankle - brachial index ≤ 0.6 in the study leg
  3. Patient has failed adequate medical therapy which included

    1. Exercise program
    2. Smoking cessation therapy
    3. Control of diabetes, hypertension and dyslipidemias
    4. Antiplatelet therapy
  4. Preoperative angiography or CT angiography shows superficial femoral artery occlusion AND required Humacyte Human Acellular Vessel (HAV) length of ≤ 40cm. 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
  5. Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff
  6. Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery
  7. Distal anastomosis is expected to be to the popliteal artery above the knee
  8. 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
  9. 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
  10. Aged 18 to 85 years old, inclusive
  11. Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
  12. Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening
  13. Adequate liver function, defined as serum bilirubin ≤ 1.5 mg/dL; GGT ≤ 3x upper limit of normal ; AST, ALT, and alkaline phosphatase ≤ 2x upper limit of normal and INR ≤ 1.5 at screening
  14. Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
  15. Life expectancy of at least 1 year

Exclusion Criteria:

  1. Leg at high risk of amputation (SVS WIfI stage 4)
  2. Recent trauma to the leg receiving the HAV
  3. Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
  4. Distal anastomosis planned to a below knee artery
  5. 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
  6. Stroke within six (6) months prior to study entry (Day 1)
  7. Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR<45mL/min)
  8. Uncontrolled diabetes (HbA1c >10% at screening)
  9. Treatment with any investigational drug or device within 60 days prior to study entry (Day 1)
  10. Cancer that is being actively treated with a cytotoxic agent
  11. AIDS / HIV infection
  12. Documented hypercoagulable state or history of 3 or more DVTs or other spontaneous intravascular thrombotic events within the previous 5 years
  13. Bleeding diathesis
  14. Ongoing treatment with vitamin K antagonists or oral direct thrombin inhibitors or factor Xa inhibitors (e.g. dabigatran, apixaban or rivaroxaban )
  15. Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative leg
  16. 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
  17. Active autoimmune disease - symptomatic or requiring ongoing drug therapy
  18. Active local or systemic infection (WBC > 15,000/mm3)
  19. Known serious allergy to aspirin
  20. 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)
  21. Previous enrollment in this study
  22. Employees of the sponsor or patients who are employees or relatives of the investigator
  23. 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.)

Information from the National Library of Medicine

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


Contacts
Contact: Angela Rose, MBA 919-313-9633 ext 185 rose@humacyte.com
Contact: Brant Hamel, PhD 919-313-9633 ext 245 hamel@humacyte.com

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan Vascular Center Recruiting
Flint, Michigan, United States, 48507
United States, New Jersey
Overlook Medical Center Recruiting
Summit, New Jersey, United States, 07901
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Humacyte, Inc.
Atlantic Research Group
Investigators
Study Director: Jeffrey Lawson, MD, PhD Humacyte, Inc.

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT02887859     History of Changes
Other Study ID Numbers: CLN-PRO-V004
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs