Study design
ICH
Randomized, comparator-controlled, open label, assessor-blinded multicentric trial (Södersjukhuset in Stockholm, Sweden and Sahlgrenska University Hospital in Gothenburg, Sweden). The European Cardiovascular Research Center (CERC) core lab analyzed the OCT-derived endpoints and was blinded to the patient’s identity, allocation arm and the baseline clinical characteristics. The CERC is a core lab totally independent from our research institution. The study was approved by the Ethical Review Board of the Stockholm County Regional Council, the Medical Products Agency and the Swedish Radiation Safety Authority and complies with the current ICH E6 (R2), good clinical practice guidelines and the Helsinki declaration.