Andrew Holden, director of Interventional Services at Auckland City Hospital and associate professor of Radiology at Auckland University School of Medicine, New Zealand, presented positive preliminary observations from a sub-study of the STANCE trial. Holden presented data highlighting the STANCE trial’s pioneering use of Optical Coherence Tomography (OCT) to prospectively evaluate the performance of the Stanza SFA self-expanding, bioresorbable scaffold (480 Biomedical). The presentation was delivered at the Late-Breaking Clinical Trials session of the 10th Annual Vascular InterVentional Advances (VIVA) Meeting (Las Vegas, USA, 9–12 October 2012).
STANCE is a prospective, single-arm, multicentre first-in-man trial of the Stanza scaffold in patients with symptomatic atherosclerotic superficial femoral artery (SFA) disease. The trial is being conducted at sites in New Zealand, Australia, Germany and Austria. Optical coherence tomography is being used at three STANCE trial sites to assess Stanza scaffold deployment post-procedure, and to visualise tissue coverage and scaffold bioresorption at 6 months in half the sub-study cohort, and at 12 months in the other half.
A release from 480 Biomedical announced that the first twenty-five patients enrolled in the study have been successfully implanted with the Stanza scaffold. The presentation at VIVA included results from the first eight treated patients at Auckland City Hospital.
“To date, we have seen excellent acute scaffold performance with post-procedural images showing the scaffold well apposed to the vessel wall,” said Holden, principal investigator for the trial. “The potential to effectively treat superficial femoral artery disease without a permanent metallic implant is welcome news for our patients.”
“We are excited to be advancing our Stanza scaffold through the clinic, and also to be demonstrating the feasibility and utility of optical coherence tomography imaging for infrainguinal procedures,” said Maria Palasis, executive vice president and chief technology officer of 480 Biomedical. “Our goal in the STANCE trial is to establish the mechanical performance of our novel self-expanding bioresorbable scaffold design, and we are very encouraged by the data we have seen so far.”