NCT05027984 Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
| NCT ID | NCT05027984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro per la Lotta Contro l'Infarto - Fondazione Onlus |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,420 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,420 participants in total. It began in 2021-06-30 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion criteria: * 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. * Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial. * 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. * Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel. * Coronary anatomy unsuitable for PCI. * Comorbidities that might interfere with completion of the study procedures. * 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.
Contact & Investigator
Francesco Prati, MD
PRINCIPAL INVESTIGATOR
Centro per la Lotta con l'Infarto - CLI Foundation
Frequently Asked Questions
Who can join the NCT05027984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05027984 currently recruiting?
Yes, NCT05027984 is actively recruiting participants. Contact the research team at fprati61@gmail.com for enrollment information.
Where is the NCT05027984 trial being conducted?
This trial is being conducted at Pátrai, Greece, Ascoli Piceno, Italy, Acquaviva delle Fonti, Italy, Bari, Italy and 11 additional locations.
Who is sponsoring the NCT05027984 clinical trial?
NCT05027984 is sponsored by Centro per la Lotta Contro l'Infarto - Fondazione Onlus. The principal investigator is Francesco Prati, MD at Centro per la Lotta con l'Infarto - CLI Foundation. The trial plans to enroll 1,420 participants.