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)
ClinicalTrials.gov ID: NCT02539966
Sponsor
Primary endpoints
Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months.
CERC Services
- Regulatory submissions
- Project management
- Safety management
- Monitoring activities
Countries
8 countries: Belgium, Brazil, Denmark, France (managed by CERC), Germany, Netherlands, Poland and Slovenia
Number of investigational sites
28 investigational centers (4 managed by CERC)
Number of patients
272
