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Summary

for people ages 18–85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

Peripheral Artery Disease Glucuronyl glucosamine glycan sulfate

Eligibility

You can join if…

Open to people ages 18–85

  1. Patients with disabling symptomatic peripheral arterial disease
  2. Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
  3. Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
  4. Ankle - brachial index ≤ 0.6 in the study leg
  5. Patient has failed adequate medical therapy which included
  6. Exercise program
  7. Smoking cessation therapy
  8. Control of diabetes, hypertension and dyslipidemias
  9. Antiplatelet therapy
  10. 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
  11. Preoperative imaging shows at least one below knee vessel patent to the ankle with good runoff
  12. Proximal HAV anastomosis is expected to be to the common femoral artery below the inguinal ligament or to the superficial femoral artery
  13. Distal anastomosis is expected to be to the popliteal artery above the knee
  14. 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
  15. 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
  16. . Aged 18 to 85 years old, inclusive
  17. . Hemoglobin ≥ 10g/dL and platelet count ≥ 100,000/mm3 at screening
  18. . Other hematological and biochemical parameters within a range considered acceptable for the administration of general anesthesia at screening
  19. . 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
  20. . Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
  21. . Life expectancy of at least 1 year

You CAN'T join if...

  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.)

Locations

  • Michigan Vascular Center accepting new patients
    Flint, Michigan, 48507, United States
  • Duke University accepting new patients
    Durham, North Carolina, 27708, United States
  • Brigham and Women's Hospital accepting new patients
    Boston, Massachusetts, 02115, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Humacyte, Inc.
ID
NCT02887859
Phase
Phase 2
Study Type
Interventional
Last Updated
May 1, 2017
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