Study design
AGENT Japan, a prospective, single-blind, non-inferiority study, randomized patients with SVD to receive either Agent or SeQuent Please in a 2:1 fashion. This trial also includes a single-arm substudy that evaluates the safety and effectiveness of Agent in patients with ISR of a previously treated lesion.This study was approved by the Institutional Review Board at each site prior to enrollment and complied with the principles of the Declaration of Helsinki, Good Clinical Practice (GCP), Order for Enforcement of the Pharmaceutical and Medical Device Law and all applicable local and federal regulations. The AGENT Japan study is registered on clinicaltrials.gov under NCT04058990.Study methods and primary end point data for the SV RCT and ISR substudy have been described previously [DAPT with aspirin and a P2Y12 inhibitor was prescribed for at least 3 months post-procedure. Clinical follow-up was scheduled at hospital discharge, 30 days, and 6 months after PCI, then annually between 1 and 5 years. Protocol-specified coronary angiography was required at baseline and at the 6-month follow-up.