Brief summary

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)

Primary endpoints

Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. 

CERC Services

Study management for 4 French sites :

Clinical trial documentation translation,

Submission,

Set-up activities,

Project Management,

Monitoring,

Safety reporting.

Countries

8 countries: Belgium, Brazil, Denmark, France, Germany, Netherlands, Poland and Slovenia.

Centers number

28 investigational centers