Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
FANTOM II Long Lesion Study: Initial Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold in Long Lesions – First Report: 3 Year Outcomes
M. Lutz1, S. Pyxaras2, J. Weber-Albers3, M. Rosenberg4, S. Kische5, N. Frey6, für die Studiengruppe: FANTOM II
1Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Kiel; 2Med. Klinik I - Kardiologie, Klinikum Fürth, Fürth; 3Klinik für Innere Medizin I, St.-Johannes-Hospital Dortmund, Dortmund; 4Medizinische Klinik I, Klinikum Aschaffenburg, Aschaffenburg; 5Klinik für Innere Medizin - Kardiologie und konserv. Intensivmedizin, Vivantes Klinikum im Friedrichshain, Berlin; 6Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie, Universitätsklinikum Heidelberg, Heidelberg;

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. Post implantation results were analyzed by OCT in all cases.

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 data set through 36 months of follow-up will be available in March and reported for the first time at the DGK 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 with stable outcomes through 3 years 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.
https://dgk.org/kongress_programme/jt2022/aP531.html