Why OCT and IVUS are underused in complex coronary interventions

Assessment of Barriers Limiting Optical Coherence Tomography Penetration in Actual Clinical Practice & Training (OCT2ACT) Study

This project will see why doctors do or don't use intracoronary imaging (OCT and IVUS) during complex PCI in people with coronary artery disease.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Consorzio Futuro in Ricerca (Academic / other)
• Locations: 2 sites (Bergamo and 1 other locations)
• Trial ID: NCT07193693 on ClinicalTrials.gov

What this trial studies

This observational study compares patients undergoing complex percutaneous coronary intervention who receive intracoronary imaging with those who do not, to identify practical barriers to OCT and IVUS use. Patients are grouped into cohorts based on imaging use according to guidelines, non-use despite guideline indications, or use outside guideline recommendations, and demographic, procedural, and logistic data will be collected. The study focuses on high-complexity lesion types such as long lesions, true bifurcations, and left main bifurcations. Investigators aim to document obstacles like time constraints, costs, device availability, and operator experience that limit imaging uptake.

Who should consider this trial

Good fit: Ideal candidates are adults undergoing clinically indicated PCI for complex coronary lesions—long lesions (>38 mm), true bifurcations with a side-branch >2.5 mm (Medina 1.1.1), or left main bifurcation—who either receive or do not receive intracoronary imaging.

Not a fit: Patients not undergoing complex PCI, those with other cardiac conditions not requiring intracoronary imaging, or those who refuse consent are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could help hospitals and policymakers remove obstacles to routine OCT/IVUS use and thereby increase adoption of guideline-recommended imaging in complex PCI, which may improve patient outcomes.

How similar studies have performed: Randomized trials have shown that IVUS and OCT guidance can reduce hard endpoints including mortality in complex PCI, but studies specifically examining real-world reasons for their underuse are novel.

Eligibility criteria

1. Cohort intracoronary imaging NO

   • Inclusion criteria

   Patients undergoing clinically indicated PCI and having at least one of the following criteria (suggestive for complex PCI) without receiving intracoronary imaging:
   * Long lesion (\>38 mm)
   * True bifurcation involving side-branch with a reference diameter of \>2.5 mm and Medina 1.1.1
   * Left main bifurcation

     • Exclusion criteria
   * Refusal of informed consent
2. Cohort intracoronary imaging YES according to guidelines recommendation

   • Inclusion criteria

   Patients undergoing clinically indicated PCI with the guidance of intracoronary imaging (OCT or IVUS) and having at least one of the following criteria (suggestive for complex PCI) receiving imaging:
   * Long lesion (\>38 mm)
   * True bifurcation involving side-branch with a reference diameter of \>2.5 mm and Medina 1.1.1
   * Left main bifurcation

     • Exclusion criteria
   * Refusal of informed consent
3. Cohort intracoronary imaging YES outside guidelines recommendation

   * Inclusion criteria Patients undergoing IVUS or OCT use.
   * Exclusion criteria

     * Long lesion (\>38 mm)
     * True bifurcation involving side-branch with a reference diameter of \>2.5 mm and Medina 1.1.1
     * Left main bifurcation
     * Refusal of informed consent

Where this trial is running

Bergamo and 1 other locations

• ASST Papa Giovanni XXIII — Bergamo, Italy (Recruiting)
• Ospedale San Martino — Genova, Italy (Recruiting)

Study contacts

• Principal investigator: Vergallo Rocco — Ospedale Policlinico San Martino
• Study coordinator: Veronica Lodolini, BSc

Conditions Coronary Artery Disease); IVUS; OCT; PCI