Barriers Limiting OCT Penetration in Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConsorzio Futuro in Ricerca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cohort intracoronary imaging NO
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
Disqualifiers
Refusal of informed consent
Cohort intracoronary imaging YES according to guidelines recommendation
Long lesion (>38 mm)
True bifurcation involving side-branch with a reference diameter of >2.5 mm and Medina 1.1.1
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 3 trial groupsGroup A: Cohort intracoronary imaging NO
Group B: Cohort intracoronary imaging YES according to guidelines recommendation
Group C: Cohort intracoronary imaging YES outside guidelines recommendation
Trial outcomes
Primary outcomes
1
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
Time frame
From the enrollment to the end of the procedure2
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.
Time frame
From enrollment to the end of the procedure3
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
Time frame
from enrollment to the end of the procedureSecondary outcomes
1
Cohort intracoronary imaging NO: secondary endpoints
Percentage of PCI matching inclusion/exclusion criteria
Time frame
from September to December 20252
Cohort intracoronary imaging NO: secondary endpoints
Percentage of PCI where intracoronary imaging is used as compared to overall volume of PCI
Time frame
from September to December 20253
Cohort intracoronary imaging NO: secondary endpoints
Percentage of PCI where intracoronary imaging is used as compared to overall volume of PCI matching inclusion/exclusion criteria
Time frame
from September to December 20254
Cohort intracoronary imaging NO: secondary endpoints
Association between baseline and procedural characteristics and missing use of intracoronary imaging
Time frame
from September to December 2025Sponsors and contacts
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Source ClinicalTrials.gov