NCT07193693Completed
Barriers Limiting OCT Penetration in Clinical Practice
Assessment of Barriers Limiting Optical Coherence Tomography Penetration in Actual Clinical Practice & Training (OCT2ACT) Study
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1189 (actual)
- First submitted
- 10 Sept 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 15 May 2026
- Lead sponsor
- Consorzio Futuro in Ricerca
- Diseases
- Coronary artery disease
- NCT number
- NCT07193693
What you commit to
- Study type: Observational
- Participants enrolled: 1189
- From 15 Sept 2025 to the primary completion date, 15 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Ospedale San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.