AIMS: The primary objective of the FANTOM II Long Lesion study was to evaluate the safety and performance of native coronary artery stenting of lesions ≥ 20mm in length using one or more Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffolds.  Fantom is a fully resorbable scaffold, manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs.  Fantom is completely radiopaque enabling multiple scaffolds to be placed in a precise edge to edge configuration allowing for complete coverage of longer target lesions.  

Methods:  The FANTOM II Long Lesion study is a prospective, multicenter trial, which enrolled 32 patients with 33 de novo coronary stenosis with reference vessel diameters between 2.5 to 3.5 mm in diameter and lesion lengths ≥ 20mm.  In this study all lesions were pre-dilated using a 1:1 NC balloon and then subsequently assessed to determine vessel diameter and lesion length.  Once sizing was complete, between one and three scaffolds were selected to enable complete target lesion coverage. 

Results:  In this study acute technical success, acute procedural success and clinical procedural success rates as defined in the clinical protocol were 100% (33/33) in all cases. Angiographic imaging results from for all patients through 6 months of follow-up as well as MACE, TLF and Scaffold Thrombosis through 12 months of follow-up show no event (0%). The complete 24 months follow up will be available and reported for the first time at the conference.

Conclusions: As in the Fantom II Trial which was used as a basis for obtaining CE Mark, the Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable initial acute safety in this first cohort of patients with more complex lesions. Longer-term follow-up through 5 years is ongoing to examine the late outcomes with this novel device.