RENASCENT II: First in Human Evaluation of a Novel Sirolimus-Eluting Ultra-High Molecular Weight APTITUDE(R) Bioresorbable Scaffold: 9-and 24-Months Imaging and Clinical Results.

AIMS: The novel sirolimus-eluting ultra-high molecular weight 115-microns strut thickness APTITUDE(R) Bioreabsorbable vascular scaffold (BRS) (Amaranth Medical Inc., Mountain View, CA) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to clinically available BRS technologies. RENASCENT II is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the APTITUDE(R) BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: APTITUDE(R) BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischemia driven target lesion revascularization (TLR) at 9-and 24-months. A total of 60 patients were enrolled. All patients underwent lesion pre-dilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100% respectively. Angiographic late lumen loss was 0.19 +/- 0.26mm at 9-months and 0.3 +/- 0.41mm at 24-months. At 9-months, TVF occurred in 2/59 (3.4%) due to TV-MI but no TLR. No further cases of TVF, MACE or stent thrombosis were reported upto 24-months follow-up. CONCLUSIONS: In this multi-center prospective study, the APTITUDE(R) BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-months clinical follow up.