The first 25 patients enrolled in 480 Biomedical's STANCE trial have been successfully implanted with the company's fully self-expanding, bioreabsorbable scaffold. Dr Andrew Holden presented data highlighting the STANCE trial's use of optical coherence tomography (OCT) to prospectively evaluate the performance of 480's Stanza SFA (superficial femoral artery) scaffold. The presentation was delivered at the late-breaking clinical trials session of the 10th Annual Vascular InterVentional Advances (VIVA) meeting, held in Las Vegas, NV.
STANCE is a prospective, single-arm, multicentre, first-in-man trial of the Stanza self-expanding bioreabsorbable scaffold in patients with symptomatic atherosclerotic SFA disease. The trial is being conducted at sites in New Zealand, Australia, Germany and Austria. OCT is being used at three STANCE trial sites to assess Stanza scaffold deployment post-procedure, and to visualise tissue coverage and scaffold bioreabsorption at six months in half the sub-study cohort, and at 12 months in the other half. The presentation at VIVA included results from the first eight treated patients at Auckland City Hospital.