ABSTRACT
Bioresorbable scaffolds (BRSs) may potentially overcome the many pitfalls related to drug eluting stents (DESs). The primary objective of this study was to evaluate and effectiveness of the Mirage Microfiber Sirolimus Eluting Coronary Scaffold (MMSES) compared to the Bioresorbable Vascular Scaffold (BVSs) in the treatment of stenotic target lesions located in native coronary arteries. The secondary objectives of this study were to establish the long-term safety, effectiveness, and performance of the MMSES, assessed at multiple time points through assessment of clinical and/or angiographic, Optical coherence tomography (OCT), and intravascular ultrasound (IVUS) data. The high mechanical strength of polylactide (PLA) monofilament results in the high radial strength of MMSES. MMSES has a circular strut that is believed to accelerate the re-endothelialization process and minimize the risk for scaffold thrombosis. PLA monofilament technology offers great flexibility in manufacturing bioresorbable scaffolds. MMSES was made into various sizes that were virtually the same as those in DESs.
