The first-in-man experience results with a new bioresorbable scaffold for superficial femoral artery lesions were presented by Andrew Holden, Auckland, New Zealand, yesterday. Holden described the Stanza Bioresorbable Scaffold System from 480 Biomedical and initial case experience from the first patients treated in the STANCE trial.
The Stanza scaffold is the first self-expanding bioresorbable technology being developed for treatment of atherosclerotic disease in the superficial femoral artery, Holden said. He added that “the scaffold design is a composite structure of strong PLGA fibers in combination with an elastomer. This design enables the scaffold’s key attributes of flexibility and radial stiffness, similar to self-expanding metallic stents. Preclinical animal studies demonstrate biocompatible resorption of the scaffold over six to 12 months. The scaffold, which uses a conventional retractable sheath delivery system, is being tested in the STANCE trial in target lesions up to 100mm in length and diameters between 4.6–6mm.”
The STANCE trial is a prospective, single-arm, multicentre trial of the Stanza scaffold in patients with symptomatic atherosclerotic disease of the superficial femoral artery. The primary endpoint of the trial is major adverse events at six months, with evaluation of vessel patency and other functional and quality of life metrics assessed three, six, 12 and 24 months post-procedure. 480 Biomedical expects to enrol up to 60 patients in the STANCE study at sites in New Zealand, Australia and Europe by the end of 2012.
Holden told delegates that, in the Auckland City Hospital experience with nine patients treated to date, 100% procedural success was achieved with the Stanza scaffold. He noted that the scaffold was accurately deployed in the targeted superficial femoral artery lesion and blood flow was restored to the leg as evidenced by angiography and Doppler ultrasound.
“At Auckland City Hospital, treated vessels were also imaged using optical coherence tomography (OCT), a modality that has been used in coronary interventions but never before used in clinical trials for superficial femoral artery treatment. Post-procedure OCT images showed good vessel wall apposition with the Stanza scaffold. Additional OCT and MR angiographic analysis of the treated area will be conducted at six and 12-months to enable visualisation of the scaffold as it dissolves over time,” he said.