AIMS: The primary objective of the FANTOM Post Market study was to evaluate the continued safety and performance of native coronary artery stenting with the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold in every-day clinical practice.  Fantom encore is a fully resorbable scaffold, manufactured from TyroCore, which is composed mainly of an iodinated, polycarbonate copolymer of tyrosine analogs.  Fantom encore is completely radiopaque and is comprised of thin struts (95-115 micron) that facilitate device delivery and precise target lesion treatment.

Methods:  The FANTOM Post Market study is a prospective, multicenter trial which plans to enroll up to 1,500 patients with de novo coronary stenosis with reference vessel diameters between 2.5 to 3.75 mm in diameter and lesion lengths £ 20mm.  In this study all lesions were to be pre-dilated using a 1:1 NC balloon and then subsequently assessed to determine vessel diameter and lesion length.  Once sizing was complete, the Fantom Encore scaffold was implanted using standard stent implantation techniques. Post dilation was then recommended in all cases to a minimum of 16 atm.  Optimal implantation was then determined using standard angiographic techniques with the highly recommended option of using OCT at the physician’s discretion.  All patients in this trial will be followed for 5 years post-implant.

Results: This initial presentation will provide the current ongoing analysis of the clinical results from the first 75 patients enrolled through 30 days of follow-up.  The presented results will include acute technical success, acute procedural success and clinical procedural success rates as defined in the clinical protocol. In addition, clinical outcomes such as MACE, TLF and Scaffold Thrombosis will be available 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 Post Market study of every-day clinical use.  The study is continuing to enroll patients and future results will be reported as they become available.