Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

Prior treatment

• Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
• Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel.
• Planned major surgery necessitating interruption of dual antiplatelet.
• Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.

Other illness

• Advanced heart failure (NYHA III-IV)
• Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.

Lab values

• Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).

Other

• Female with childbearing potential or lactating.
• Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
• Lesions located in the left main coronary artery
• Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
• Coronary anatomy unsuitable for PCI.
• Comorbidities that might interfere with completion of the study procedures.

• Age of at least 18 years.
• Diagnosis of acute coronary syndrome.
• Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel.
• Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
• Life expectancy \>3 years.