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Peripheral Arterial DiseaseNCT01872208

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

A study testing HAV implantation in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Humacyte, Inc. at 3 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
HAV implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesPoland
Study dates
10 Oct 2013to 18 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

Poland3 sites

  • Clinic of Vascular Surgery and Angiology; Medical University in Lublin

    Lublin, 20-081

  • Pomeranian University in Szczecin; Clinic of General, Vascular Surgery and Angiology

    Szczecin, 70-111

  • Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery

    Wroclaw, 51-124

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
HAV implantation
Keywords
PAD, Atherosclerosis, Peripheral circulation, Blood Vessel Prosthesis, Tissue-Engineered Vascular Graft, Vascular Prosthesis Implantation, Femoro-Popliteal Bypass
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAV implantationBiological

    Also called Human Acellular Vessel

    Patients will be implanted with a Human Acellular Vessel (HAV) as an above-knee femoro-popliteal bypass graft using standard vascular surgical techniques.

Study groups in NCT01872208
Study groupRoleWhat they receive
Human Acellular Vessel (HAV)ExperimentalHAV implantation to study participants.
Receives: Biological: HAV implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HAV characteristics

    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.

    Measured: From day 5 to month 24 after HAV implantation.

  2. Change in HAV patency rate

    Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAV by Doppler ultrasound.

    Measured: From day 5 to month 24 after HAV implantation.

  3. Change in frequency and severity of Adverse Events

    Frequency and severity of AEs of each patient will be documented.

    Measured: From day 1 to month 24 after HAV implantation.

  4. Change in hematology, coagulation and clinical chemistry parameters

    Change from baseline in hematology, coagulation and clinical chemistry parameters.

    Measured: From baseline to week 26 after HAV implantation.

Secondary outcomes (6)

  1. Change from baseline in Panel Reactive Antibody (PRA)

    Assess changes in the Panel Reactive Antibody response over 6 months after graft implantation.

    Measured: From baseline to week 26 after HAV implantation.

  2. Development of IgG antibodies

    Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG over the 6 months after implantation.

    Measured: From baseline to week 26 after HAV implantation.

  3. HAV patency rates

    To determine the patency rates of the graft (primary, primary assisted and secondary).

    Measured: At months 6, 12, 18 after HAV implantation.

  4. Graft interventions

    Determine the rates of interventions needed to maintain / restore patency in the graft.

    Measured: At days 5, 15, weeks 6, 12, 16, months 12, 18, 24 after HAV implantation.

  5. Effect of graft implantation on PAD symptoms

    Assessment of any effect of graft implantation on claudication, rest pain and ischemic ulcers.

    Measured: From baseline to weeks 6, 12, 26, months 12, 18, 24 after HAV implantation.

  6. Effect of graft on ankle-brachial index (ABI)

    Assessment of any effect of the graft on ankle-brachial index (ABI).

    Measured: From baseline to weeks 6, 12, 26, months 12, 18, 24 after HAV implantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2013 (estimated)
  2. Study start10 Oct 2013
  3. Primary completion30 May 2016
  4. Study completion18 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01872208
Sponsor's protocol ID
CLN-PRO-V002
Status last verified
Nov 2024
First submitted
22 May 2013
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Gutowski P, Gage SM, Guziewicz M, Ilzecki M, Kazimierczak A, Kirkton RD, Niklason LE, Pilgrim A, Prichard HL, Przywara S, Samad R, Tente B, Turek J, Witkiewicz W, Zapotoczny N, Zubilewicz T, Lawson JH. Arterial reconstruction with human bioengineered acellular blood vessels in patients with peripheral arterial disease. J Vasc Surg. 2020 Oct;72(4):1247-1258. doi: 10.1016/j.jvs.2019.11.056. Epub 2020 Feb 21.

    PubMed 32093913

Questions about this trial

What is this clinical trial studying?

A study testing HAV implantation in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Humacyte, Inc. at 3 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HAV characteristics (time frame: From day 5 to month 24 after HAV implantation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01872208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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