AzTrials
AzTrials

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))OCT2ACTNCT07193693

Barriers Limiting OCT Penetration in Clinical Practice

An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Consorzio Futuro in Ricerca at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,189 participants
Where
2 sitesItaly
Study dates
15 Sep 2025to 15 May 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • ASST Papa Giovanni XXIII

    Bergamo

  • Ospedale San Martino

    Genova

Other trials in Italy

About this study

Official title: Assessment of Barriers Limiting Optical Coherence Tomography Penetration in Actual Clinical Practice & Training (OCT2ACT) Study

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:

Read more
  • 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.
Read the detailed description

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 main reasons/barriers limiting the use of intracoronary imaging in complex PCI where it is indicated as suggested by guidelines
  • The main reasons behind the selection of IVUS or OCT in complex PCI
  • In complex PCI guided by OCT, How OCT can influence the procedural planning and optimization in complex clinical settings.

The OCT2ACT is an observational, prospective, multicenter, investigator-driven study.

Participating centers will include three different cohorts of patients:

  1. Cohort intracoronary imaging NO In this cohort, the investigators will include all the patients matching inclusion/exclusion criteria, but in whom intracoronary imaging (IVUS or OCT) was not used (operator's decision). The aim is to have a description of the main reasons/barriers that led to the avoidance of imaging utilization.
  2. Cohort intracoronary imaging YES according to guidelines recommendation In this cohort, the investigators will include all the patients matching inclusion/exclusion criteria in whom intracoronary imaging (IVUS or OCT) was used (operator's decision) according to guidelines recommendation. The aim is to understand the main reasons behind the decision to use IVUS or OCT and the clinical advantages perceived by the operators.
  3. Cohort intracoronary imaging YES outside guidelines recommendation In this cohort, the investigators will include all the patients matching inclusion/exclusion criteria in whom OCT was used (operator's decision) outside Guidelines recommendations. The aim is to understand the main reasons behind the decision to use OCT outside guidelines recommendation, its safety and the clinical advantages perceived by the operators.

After Ethic Committee approval and site initiation visit, each participating center will recruit consecutive patients for a time window of 3 months.

Keywords
IVUS, OCT, PCI
Medical subject headings
Coronary Artery Disease, Angina Pectoris, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07193693
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From the enrollment to the end of the procedure

  2. 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.

    Measured: From enrollment to the end of the procedure

  3. 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

    Measured: from enrollment to the end of the procedure

Secondary outcomes (11)
  1. Cohort intracoronary imaging NO: secondary endpoints

    Percentage of PCI matching inclusion/exclusion criteria

    Measured: from September to December 2025

  2. Cohort intracoronary imaging NO: secondary endpoints

    Percentage of PCI where intracoronary imaging is used as compared to overall volume of PCI

    Measured: from September to December 2025

  3. 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

    Measured: from September to December 2025

  4. Cohort intracoronary imaging NO: secondary endpoints

    Association between baseline and procedural characteristics and missing use of intracoronary imaging

    Measured: from September to December 2025

  5. 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.

    Measured: from enrollment to the end of the procedure

  6. 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.

    Measured: from enrollment to the end of the procedure

  7. 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.

    Measured: from enrollment to the end of the procedure

  8. Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints

    Association between baseline and procedural characteristics and IVUS/OCT preference

    Measured: from September to December 2025

  9. Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints

    Description of timing and modality of the intracoronary imaging

    Measured: from September to December 2025

  10. Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints

    Description of the operator's perceived advantages by intracoronary imaging use

    Measured: from September to December 2025

  11. Cohort intracoronary imaging YES outside guidelines recommendations: secondary endpoints

    Description of OCT penetration over IVUS in bifurcations, LM and stent failure

    Measured: from September to December 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,189 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07193693
Sponsor's protocol ID
OCT2ACT
Acronym
OCT2ACT
Status last verified
Oct 2026
First submitted
10 Sep 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39210710
  • Biscaglia S, Trabattoni D, Canova P, Boi A, Bruno F, Caretta G, Biccire F, Mattesini A, Preti G, Muraca I, Burzotta F, Cerrato E, Mancini G, Secchi S, Tarantini G, Cicala M, Pesarini G, Verdoia M, Farina J, Vadala G, Vergallo R. Intracoronary Imaging Implementation Gap in Contemporary PCI: The OCT2ACT Study. JACC Adv. 2026 Jul 17;5(8):102982. doi: 10.1016/j.jacadv.2026.102982. Online ahead of print.

    PubMed 42468158

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Consorzio Futuro in Ricerca at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort intracoronary imaging NO: Reasons/barriers for not using intracoronary imaging (time frame: From the enrollment to the end of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07193693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in