Actively Recruiting

Age: 18Years +
All Genders
NCT07193693

Barriers Limiting OCT Penetration in Clinical Practice

Led by Consorzio Futuro in Ricerca · Updated on 2026-01-06

1000

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Barriers Limiting OCT Penetration in Clinical Practice

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 2 locations

1

ASST Papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

2

Ospedale San Martino

Genova, Italy

Actively Recruiting

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Research Team

V

Veronica Lodolini, BSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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