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 range18 Years – 85 Years
SexALL
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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
✕. 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
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)