Barriers Limiting OCT Penetration in Clinical Practice

NCT07193693 | Recruiting

• 1 other identifier: OCT2ACT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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:
• 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.
• Cohort intracoronary imaging YES according to guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging as recommended by guidelines.
• 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))

Keywords

IVUS; OCT; PCI

Outcome Measures

Primary Outcomes (3)

• Cohort intracoronary imaging NO: Reasons/barriers for not using intracoronary imaging

  As suggested in the consensus document by Cabana et al, the main reasons/barriers will be classified according to the following groups: Attitudes (lack of agreement and inertia of previous practice): * Clinical and angiographic data are sufficient * Intracoronary imaging would not change my PCI strategy * Intracoronary imaging has low added value on improving clinical outcome Knowledge (lack of awareness and familiarity): * Intracoronary imaging not feasible for technical or anatomical reasons (e.g., tortuous vessels, etc.) * Lack of confidence in interpretation of images * Lack of confidence in translating imaging features into an actionable PCI plan * Inadequate support by device specialists in the cath lab Behavior (external barriers): * Time constraint * Device costs * Absence of adequate coding / reimbursement

  From the enrollment to the end of the procedure

• Cohort intracoronary imaging YES according to guidelines recommendations: Reasons behind the selection of IVUS or OCT

  The operator has to define the reason behind the choice of the imaging modality with particular regard to the anticipated benefit related to such choice.

  From enrollment to the end of the procedure

• Cohort intracoronary imaging YES outside guidelines recommendations: Reasons behind the selection of OCT or IVUS outside guidelines recommendations

  The operator has to define the reason behind the choice of the imaging modality with particular regard to the anticipated benefit related to such choice in a setting that is outside guidelines recommendations

  from enrollment to the end of the procedure

Secondary Outcomes (11)

• Cohort intracoronary imaging NO: secondary endpoints

  from September to December 2025

• Cohort intracoronary imaging NO: secondary endpoints

  from September to December 2025

• Cohort intracoronary imaging NO: secondary endpoints

  from September to December 2025

• Cohort intracoronary imaging NO: secondary endpoints

  from September to December 2025

• Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints

  from enrollment to the end of the procedure

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI and receiving or not receiving imaging according to ESC indication guidelines. Patients undergoing coronary artery angiography and/or PCI and receiving imaging in a setting outside from ESC indication guidelines.

You may qualify if:

• 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

You may not qualify if:

• Refusal of informed consent
• Cohort intracoronary imaging YES according to guidelines recommendation
• 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
• Refusal of informed consent
• Cohort intracoronary imaging YES outside guidelines recommendation
• 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

Sponsors & Collaborators

• Consorzio Futuro in Ricerca: lead

Study Sites (2)

ASST Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Ospedale San Martino

Genova, Italy

RECRUITING

Related Publications (1)

• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

  PMID: 39210710 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Simone Biscaglia

  Azienda Ospedaliero Universitaria di Ferrara

  STUDY CHAIR

• Vergallo Rocco

  Ospedale Policlinico San Martino

  PRINCIPAL INVESTIGATOR

• Paolo Canova

  ASST Papa Giovanni XXIII, Bergamo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Lodolini, BSc

CONTACT

0039532236450; ldlvnc@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 26, 2025
• Study Start: September 15, 2025
• Primary Completion: December 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)