The CE-marked stent features a combination of everolimus drug and bioabsorbable PLGA polymer, whose absorption will be completed after drug elution ends at three months.
The prospective, randomized, single-blind study has enrolled the first patient at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio, US, and is designed to further assess the safety and effectiveness of the stent in treating atherosclerotic coronary lesions.
The trial is built upon the EVOLVE study, which compared the SYNERGY stent’s outcomes with the PROMUS Element stent at six months and one year.
Christ Hospital spokesperson and study principal investigator Dean Kereiakes said, "I am enthusiastic about its potential impact on patient care since the SYNERGY System was designed to reduce the risk of late adverse events and the need for prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding, as well as increased cost."
The company is expecting to enroll two thousand patients from160 sites, who will be followed for five years.
The trial data will be used for supporting the US Food and Drug Administration and Japanese regulatory approvals.
