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Using optical coherence tomography to guide treatment for vulnerable coronary lesions in heart patients

An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)

Not applicable Interventional Centro per la Lotta Contro l'Infarto - Fondazione Onlus · NCT05027984

This study tests if using a special imaging technique called optical coherence tomography can help doctors better treat certain heart patients with vulnerable coronary lesions compared to standard methods.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1420 (estimated)
Ages18 Years and up
SexAll
SponsorCentro per la Lotta Contro l'Infarto - Fondazione Onlus Academic / other
Locations34 sites (Pátrai, AX and 33 other locations)
Trial IDNCT05027984 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of an optical coherence tomography (OCT)-based strategy compared to traditional physiology-based assessments for treating intermediate coronary lesions in patients with acute coronary syndrome (ACS). Approximately 1400 patients will be randomized across 40 sites worldwide, focusing on those with single intermediate lesions that show vulnerability criteria. The study aims to determine if OCT can better identify high-risk patients and improve clinical outcomes compared to standard methods. The trial will assess the impact of these strategies on revascularization decisions and patient health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with acute coronary syndrome and having a single intermediate coronary lesion in a major coronary segment.

Not a fit: Patients with advanced heart failure, significant renal dysfunction, or those with other serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with vulnerable coronary lesions, potentially reducing the risk of cardiac events.

How similar studies have performed: Preliminary data suggests that OCT-based assessments may improve outcomes, but this specific approach is still being evaluated for its effectiveness.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Pátrai, AX and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCoronary DiseaseIschemic Heart DiseaseCoronary artery diseaseOptical coherence tomographyVulnerable plaque
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.