Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD (NCT02887859) | Clinical Trial Compass
CompletedPhase 2
Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
United States15 participantsStarted 2016-12-20
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with disabling symptomatic peripheral arterial disease
. Rutherford stage 4 or 5 who require femoro-popliteal bypass surgery or
. Rutherford stage 3 with severe claudication (less than 50 yards AND causing severe impairment of ability to work or undertake social activities)
. Ankle - brachial index ≤ 0.6 in the study leg
. Patient has failed adequate medical therapy which included
. Exercise program
. Smoking cessation therapy
. Control of diabetes, hypertension and dyslipidemias
Exclusion criteria
. Leg at high risk of amputation (SVS WIfI stage 4)
. Recent clinically significant trauma to the leg receiving the HAV
. Severe active infection (SVS foot infection grade 3) in the leg receiving the HAV
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Aneurysm Formation, Anastomotic Bleeding or Spontaneous Rupture, HAV Infection, HAV Removal, and Significant Inflammation at the HAV Implantation Site
Timeframe: 12 months
2
Number of Participants With Adverse Events
Timeframe: 12 months
3
Number of Participants With HAV Patency Rates (Primary, Primary-assisted, Secondary)
Timeframe: 12 months
4
Number of Participants With Hemodynamically Significant Stenosis (>70% by Duplex Ultrasound Criteria)
. Distal anastomosis planned to a below knee artery
. 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
. Stroke within six (6) months prior to study entry (Day 1)
. Chronic renal disease such that multiple administrations of contrast agents may pose an increased risk of nephrotoxicity (eGFR\<45mL/min)
. Uncontrolled diabetes (HbA1c \>10% at screening)