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

NCT01872208 | Completed DMC

• 1 other identifier: CLN-PRO-V002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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 peripheral arterial disease.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Disease

Keywords

PAD; Atherosclerosis; Peripheral circulation; Blood Vessel Prosthesis; Tissue-Engineered Vascular Graft; Vascular Prosthesis Implantation; Femoro-Popliteal Bypass

Outcome Measures

Primary Outcomes (4)

• 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.

  From day 5 to month 24 after HAV implantation.

• Change in HAV patency rate

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

  From day 5 to month 24 after HAV implantation.

• Change in frequency and severity of Adverse Events

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

  From day 1 to month 24 after HAV implantation.

• Change in hematology, coagulation and clinical chemistry parameters

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

  From baseline to week 26 after HAV implantation.

Secondary Outcomes (6)

• Change from baseline in Panel Reactive Antibody (PRA)

  From baseline to week 26 after HAV implantation.

• Development of IgG antibodies

  From baseline to week 26 after HAV implantation.

• HAV patency rates

  At months 6, 12, 18 after HAV implantation.

• Graft interventions

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

• Effect of graft implantation on PAD symptoms

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

Study Arms (1)

Human Acellular Vessel (HAV)

EXPERIMENTAL

HAV implantation to study participants.

Biological: HAV implantation

Interventions

HAV implantation BIOLOGICAL

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

Also known as: Human Acellular Vessel

Human Acellular Vessel (HAV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Humacyte, Inc.: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (3)

Clinic of Vascular Surgery and Angiology; Medical University in Lublin

Lublin, 20-081, Poland

Location

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

Szczecin, 70-111, Poland

Location

Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery

Wroclaw, 51-124, Poland

Location

Related Publications (1)

• 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.

  PMID: 32093913 RESULT

Related Links

• Results of the clinical study have been published

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 7, 2013
• Study Start: October 10, 2013
• Primary Completion: May 30, 2016
• Study Completion: July 18, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)