STANCE Uses OCT to Study Stanza Scaffold for SFA Disease Treatment

October 9, 2012—During a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas, Andrew Holden, MD, presented the STANCE prospective, single-arm, multicenter trial of the Stanza scaffold (480 Biomedical, Watertown, MA) in patients with symptomatic atherosclerotic disease in the superficial femoral artery (SFA).

Optical coherence tomography (OCT) is used in the trial to visualize the Stanza bioresorbable scaffold immediately after scaffold placement and at follow-up. This trial is the first clinical study using OCT to visualize the treatment of patients with a fully self-expanding bioresorbable scaffold.

The STANCE trial and OCT substudy began enrollment in late 2011. The primary safety endpoint is major adverse events at 6 months. Secondary performance endpoints include vessel patency at 3, 6, 12, and 24 months, in addition to several functional and quality-of-life metrics. To date, the OCT substudy has enrolled 16 patients; eight have been treated at Auckland City Hospital in New Zealand.

Dr. Holden reported that postprocedure OCT showed good vessel wall apposition of the Stanza bioresorbable scaffold, and the follow-up OCT images show the scaffold encapsulated by tissue. The substudy results demonstrate the ability to visualize the scaffold struts and to assess scaffold apposition tissue composition at a resolution of 15 μm.

According to Dr. Holden, the Stanza scaffold, which fully resorbs in approximately 1 year, is the first fully self-expanding bioresorbable technology being developed for treatment of atherosclerotic disease in the SFA. The scaffold design combines strong PLGA fibers with an elastomer to deliver both flexibility and radial strength. The scaffold, which uses a conventional retractable sheath delivery system, is being tested in the STANCE trial in lengths up to 100 mm.