FANTOM II is a prospective, multi-center, safety and performance study. The objective is to evaluate the safety of a new scaffold platform in native coronary arteries that includes incorporation of a deformable expansion technology and an enhanced scaffold material that is a polycarbonate co-polymer of tyrosine analogs. This will be accomplished through the implantation and evaluation of the REVA FANTOM Sirolimus-Eluting Bioresorbable Coronary scaffold comprised of Poly(I2DAT -co-lactic acid). 240 patients with clinical evidence of myocardial ischemia or a positive functional study were enrolled (117 patients were enrolled in cohort A and 123 patients in cohort B).
Clinical follow-ups are performed as follows:
Cohort A: Discharge, 1, 6, 12, 24, 36, 48 & 60 months
Cohort B: Discharge, 1, 6, 9, 12, 24, 36, 48 & 60 months
Angiographic Follow-up are performed as follows:
Cohort A: 6 Months (All Cohort A Patients)
Cohort B: 9 Months (All Cohort B Patients)
Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months.
Study management for 4 French sites :
Clinical trial documentation translation,
8 countries: Belgium, Brazil, Denmark, France, Germany, Netherlands, Poland and Slovenia.
28 investigational centers