The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.
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.
Female with childbearing potential or lactating.
Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
Advanced heart failure (NYHA III-IV)
Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Lead sponsor
Abbott Vascular (Santa Clara, USA)
Collaborator