An observational study in Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), sponsored by Consorzio Futuro in Ricerca. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Consorzio Futuro in Ricerca · Observational
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 28th largest by enrollment of the 113 observational ones, is one of 12 that started in 2025, is one of 113 observational ones, and was the 291st registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 1,189 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →302 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2025.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
101 of 302 have an industry lead sponsor. The 10 most frequent:
Consorzio Futuro in Ricerca is the lead sponsor of 5 studies on the registry; none are open to participants now.
Consorzio Futuro in Ricerca has 2 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
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 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.
The aim is to describe the main reasons/barriers for not using imaging.
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.
The last update of European Society of Cardiology (ESC) chronic coronary syndrome (CCS) guidelines upgraded the use of intravascular ultrasound (IVUS) imaging and optical coherence tomography (OCT) to class IA in the setting of complex percutaneous coronary intervention (PCI) (in particular left main, true bifurcations, and long lesions).
This strong level of recommendation is based on the recent evidence that intracoronary imaging reduces the incidence of hard clinical endpoints, including mortality, as compared to conventional angiography alone.
Yet, there is compelling evidence documenting the under-utilization of IVUS and OCT in daily practice. Many potential reasons, including time, costs, limited availability of technology, expertise of the operators have been suggested. However, no specific study investigated the reasons behind this malpractice. In particular, these reasons should be investigated now that intracoronary imaging has been upgraded to class I recommendation and that many technologies are available significantly reducing the economic burden. In addition, there are some particular anatomic subsets where OCT could be particularly helpful (bifurcations, severe calcification, acute coronary syndrome patients) and it could be interesting to assess the penetration of this technology in this subset of patients. Finally, these devices can be used also in anatomical subsets (diagnosis and procedural guidance) outside from Guidelines recommendations and it is important to assess their safety and clinical advantage in this setting.
Objective
The OCT2ACT study aims to investigate:
The OCT2ACT is an observational, prospective, multicenter, investigator-driven study.
Participating centers will include three different cohorts of patients:
After Ethic Committee approval and site initiation visit, each participating center will recruit consecutive patients for a time window of 3 months.
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.
Cohort intracoronary imaging NO
Patients undergoing clinically indicated PCI and having at least one of the following criteria (suggestive for complex PCI) without receiving intracoronary imaging:
Left main bifurcation
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:
Left main bifurcation
Cohort intracoronary imaging YES outside guidelines recommendation
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
• 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
• 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
* 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
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 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.
Time frame: 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
Time frame: from enrollment to the end of the procedure
Cohort intracoronary imaging NO: secondary endpoints
Percentage of PCI matching inclusion/exclusion criteria
Time frame: from September to December 2025
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 2025
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 2025
Cohort intracoronary imaging NO: secondary endpoints
Association between baseline and procedural characteristics and missing use of intracoronary imaging
Time frame: from September to December 2025
Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints
Procedural time. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences.
Time frame: from enrollment to the end of the procedure
Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints
Contrast media amount. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences.
Time frame: from enrollment to the end of the procedure
Cohort intracoronary imaging YES outside guidelines recommendations: safety endpoints
Procedural complications related to OCT or IVUS use. The safety endpoints will be recorded in both the cohorts intracoronary imaging YES and compared to investigate differences.
Time frame: from enrollment to the end of the procedure
Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints
Association between baseline and procedural characteristics and IVUS/OCT preference
Time frame: from September to December 2025
Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints
Description of timing and modality of the intracoronary imaging
Time frame: from September to December 2025
Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints
Description of the operator's perceived advantages by intracoronary imaging use
Time frame: from September to December 2025
Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints
Description of OCT penetration over IVUS in bifurcations, LM and stent failure
Time frame: from September to December 2025
Plan to share: No
Ran from Sep 2025 to primary completion in May 2026, 8 months.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's 8 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → May 2026, on Oct 21, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Consorzio Futuro in Ricerca