Status:
COMPLETED
Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD
Lead Sponsor:
Humacyte, Inc.
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Peripheral Arterial Disease
Peripheral Vascular Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01872208
Start Date
October 10 2013
End Date
July 18 2024
Last Update
November 13 2024
Active Locations (3)
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1
Clinic of Vascular Surgery and Angiology; Medical University in Lublin
Lublin, Poland, 20-081
2
Pomeranian University in Szczecin; Clinic of General, Vascular Surgery and Angiology
Szczecin, Poland, 70-111
3
Regional Specialist Hospital in Wroclaw; Clinic of Vascular Surgery
Wroclaw, Poland, 51-124