Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With Peripheral Arterial Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
FGK Clinical Research Sp. zo.o.
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Humacyte, Inc.
ClinicalTrials.gov Identifier:
NCT01872208
First received: May 22, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention
Peripheral Arterial Disease
Peripheral Vascular Disease
Device: HAVG graft implantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Humacyte, Inc.:

Primary Outcome Measures:
  • Change in HAVG graft characteristics [ Time Frame: From day 5 to month 24 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Change from baseline in hematology, coagulation and clinical chemistry parameters.


Secondary Outcome Measures:
  • Change from baseline in Panel Reactive Antibody (PRA) [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Assessment of any effect of the graft on ankle-brachial index (ABI).


Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

The HAVG 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 1.
  • Able to communicate meaningfully with investigative staff, competent to give written informed consent, and able to comply with entire study procedures
  • Able and willing to give informed consent
  • Life expectancy of at least 2 years

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)
  • Previous arterial bypass surgery (autologous vein or synthetic graft) in the operative limb
  • Previous angioplasty with stenting in the operative limb unless the graft anastomoses can be made at least 1cm distant from the site of the stent
  • Stenosis of >50% of the external iliac artery unless it is planned to treat this stenosis with angioplasty with or without stenting prior to, or at the time of, graft implantation
  • Distal graft anastomosis likely to be below the knee
  • Active autoimmune disease - symptomatic or requiring ongoing drug therapy
  • Active local or systemic infection (WBC > 15,000/mm3)
  • Known serious allergy to aspirin or penicillin
  • Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAVG
  • Previous enrollment in this study
  • Employees of the sponsor or patients who are employees or relatives of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872208

Locations
Poland
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
Sponsors and Collaborators
Humacyte, Inc.
FGK Clinical Research Sp. zo.o.
FGK Clinical Research GmbH
Investigators
Study Director: Alison J Pilgrim, BM MCh Phil Humacyte, Inc.
  More Information

No publications provided

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT01872208     History of Changes
Other Study ID Numbers: CLN-PRO-V002
Study First Received: May 22, 2013
Last Updated: July 3, 2014
Health Authority: Poland: Ethics Committee

Keywords provided by Humacyte, Inc.:
PAD
Atherosclerosis
Peripheral circulation
Blood Vessel Prosthesis
Tissue-Engineered Vascular Graft
Vascular Prosthesis Implantation
Femoro-Popliteal Bypass

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014