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Barriers Limiting OCT Penetration in Clinical Practice

NCT07193693 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-01-06

No results posted yet for this study

Summary

The updated guidelines from the European Society of Cardiology (ESC) for chronic coronary syndrome (CCS) have upgraded the use of IVUS and OCT to a class IA recommendation for complex PCI, based on evidence showing a reduction in serious clinical events, including mortality, compared to conventional angiography alone. Despite this, IVUS and OCT are underutilized in daily practice due to factors such as time, cost, and limited technology availability. Investigating the reasons behind this underuse is necessary, especially now that these technologies are more accessible and cost-effective. Additionally, OCT could be particularly helpful in specific cases such as coronary bifurcations and severe calcifications, warranting further evaluation of its use in these settings.

The objective of the study OCT2ACT is to investigate:

* The main reasons/barriers limiting the use of intracoronary imaging in complex PCI cases where it is indicated as suggested by guidelines;
* The main reasons behind the selection of IVUS or OCT in such patients;
* In cases where OCT is used, how this technology can influence the procedural planning and optimization in complex clinical settings.

The participating centers will include three cohorts of patients:

1. Cohort intracoronary imaging NO: patients who meet the inclusion/exclusion criteria, but did not undergo intracoronary imaging (IVUS or OCT) due to operator's decision.

The aim is to describe the main reasons/barriers for not using imaging.
2. Cohort intracoronary imaging YES according to guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging as recommended by guidelines.

The aim is to understand the main reasons for the decision to use IVUS or OCT and the clinical benefits perceived by the operator.
3. Cohort intracoronary imaging YES outside guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging (IVUS or OCT) outside.

Conditions

  • Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Sponsors & Collaborators

  • Consorzio Futuro in Ricerca

    lead OTHER

Principal Investigators

  • Simone Biscaglia · Azienda Ospedaliero Universitaria di Ferrara

  • Vergallo Rocco · Ospedale Policlinico San Martino

  • Paolo Canova · ASST Papa Giovanni XXIII, Bergamo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2025-12-15
Completion
2026-05-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193693 on ClinicalTrials.gov