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Active, Not Recruiting

NCT Number: NCT07182799

Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary revascularization, both in guiding revascularization decisions and optimizing interventional procedural outcomes, as well as assessing mid- and long-term clinical results.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Cardiovascular Diseases Chronic Coronary Syndrome Clinical Outcome Coronary Stent Implantation Heart Diseases INOCA (Ischemia With Non Obstructive Coronary Artery Disease) Infarction Ischemia MINOCA Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention (PCI) Stent Restenosis Stent Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, 00168, Italy

About this study

The OCT-AGEM registry is an ambispective, single-center observational cohort study comprising a retrospective registry (Phase I) and a prospective registry (Phase II). All patients aged 18 years or older undergoing OCT assessment during a clinically indicated coronary angiography, regardless of clinical presentation (silent ischemia, stable angina, or acute coronary syndrome), are eligible. The retrospective phase targets approximately 2,200 patients, while the prospective phase will enroll 1,000 patients, based on a current annual rate of about 150 OCT-guided procedures. Sample size calculations, informed by prior studies and preliminary experience, are as follows: for the non-interventional arm, assuming a 5% cumulative incidence of the composite endpoint and a 20% prevalence of OCT-defined vulnerable plaque, a total of 1,100 patients is required (hazard ratio [HR] 0.80; 80% power); for the interventional arm, assuming a 25% incidence of OCT-defined suboptimal stent implantation and 12% for the composite endpoint, a total of 2,100 patients will be enrolled (HR 0.85; 80% power). The study will investigate the predictive clinical value of OCT-defined vulnerable plaque in patients with non-obstructive coronary artery disease (MINOCA/INOCA) and the prognostic impact of OCT-derived plaque and stent parameters in patients undergoing percutaneous coronary intervention (PCI). The primary composite endpoint includes cardiac death, target-vessel myocardial infarction, target lesion revascularization, and stent thrombosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years;
  • Patients with clinical indication to coronary angiography undergoing intra-procedural OCT regardless of the clinical syndrome;
  • Patients with at least one end-procedural OCT assessment with a sufficient acquisition length to address the whole length of plaque or stented segments plus the proximal and distal reference segments;
  • Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethical Committee of the respective clinical site.

Exclusion criteria

  • Female with childbearing potential or lactating;
  • Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate <30 ml/min);
  • Advanced heart failure (NYHA III-IV);
  • Previous heart transplantation;
  • Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
  • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
  • Heavily calcified lesion or tortuous vessel which cannot be successfully imaged by OCT;
  • Lesion located at the coronary ostium or in angulated (>70°), sharp take-off vessel;

Treatment and study plan

Plaque vulnerability assessment

Diagnostic Test

The purpose of the OCT-AGEM registry is to confirm the clinical utility of plaque OCT assessment over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-based plaque vulnerability criteria:

  • Minimum lumen area <3.5 mm2;
  • Fibrous cap minimum thickness <65 µm;
  • Lipid arc extension >180°;
  • Presence of macrophages;
  • Superficial and deep calcified nodules
  • Ulceration/Erosion/Dissection
  • Layered tissue
  • Optical flow ratio (OFR)

Other names: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Optical flow ratio (OFR)

Stent implantation optimization

Diagnostic Test

The purpose of the OCT-AGEM registry is to confirm the clinical utility of OCT guidance during PCI over the standard coronary angiography evaluation. In particular, this ambispective cohort study aims to validate the predictive value of the OCT-derived plaque/stent parameters reported in expert consensus OCT documents, utilizing the cut-off points identified in the previous OCT registries

Other names: Minimum lumen area, Fibrous cap minimum thickness, Lipid arc extension, Presence of macrophages, Superficial and deep calcified nodules, Ulceration/Erosion/Dissection, Layered tissue, Plaque burden (%), Stent edge dissection, Reference narrowing, Stent malapposition, Minimum stent area, Stent expansion (%), In-stent tissue protrusion, Stent deformation, Stent geometry, Neo-carina shaping, Optical flow ratio (OFR)

Primary outcomes

  1. Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization (non-interventional group)

    Time frame: 1 year, 3 years, and 5 years

    Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), and target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting).

  2. Number of patients with cardiac death or target-vessel myocardial infarction or target lesion revascularization or stent restenosis/thrombosis (interventional group)

    Time frame: 1 year, 3 years, and 5 years

    Composite outcome including cardiac death (i.e. any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death), target-vessel myocardial infarction (i.e. any spontaneous myocardial infarction attributed to the vessel studied with OCT), target lesion revascularization (i.e. any target-lesion revascularization by means of percutaneous coronary intervention and coronary artery bypass grafting), and stent restenosis (i.e. angiographic in-stent stenosis/thrombosis >50%).

Secondary outcomes

  1. Predictive value of single vulnerable plaque OCT-derived criteria (non-interventional and interventional group) in terms of incidence of the primary and secondary outcomes

    Time frame: 1 year, 3 years, and 5 years

    Clinical impact of the single pre-specified OCT features of plaque vulnerability:

    • Minimum lumen area <3.5 mm2 (measured along the entire length of the assessed coronary segment );
    • Fibrous cap minimum thickness <65 µm (defined as a signal-rich homogeneous band overlying a lipid core, and measured at the thinnest portion);
    • Lipid arc extension >180° (defined as a signal-poor region diffusely bordered by overlying signal-rich bands corresponding to a fibrous cap);
    • Presence of macrophages (characterized at visual estimation as signal-rich, distinct, or confluent punctate regions that exceed the intensity of background speckle noise);
    • Superficial and deep calcified nodules (protruding mass with irregular surface characterized by signal-poor heterogeneous regions with sharp borders)
    • Ulceration/Erosion/Dissection (linear rim of tissue with a width ≥200μm and a clear separation from the vessel wall or underlying plaque)
    • Layered tissue (plaque with one or more evident layers)

  2. Predictive clinical value of single pre-specified plaque/stent OCT features in patients undergoing percutaneous coronary revascularization (interventional group) in terms of incidence of the primary and secondary outcomes

    Time frame: 1 year, 3 years, and 5 years

    Clinical impact of the single pre-specified OCT features of the stented plaques:

    • Edge dissection with a width ≥200μm (linear rim of tissue with a width ≥200μm and a clear separation from the vessel wall or underlying plaque);
    • Reference narrowing: lumen area <4.5mm2 in the presence of significant residual plaque adjacent to stent endings (including 5mm beyond stent borders);
    • Malapposition >200μm (stent-adjacent vessel lumen distance >200μm);
    • In-stent minimum lumen area (MLA) <4.5mm2 (measure of smaller in-stent lumen area);
    • In-stent MLA <80% (expressed as % of the average reference lumen areas);
    • Intrastent plaque/thrombus protrusion ≥500μm in thickness (tissue prolapsing between stent struts extending inside a circular arc connecting adjacent struts or intraluminal mass ≥500μm in thickness with no direct continuity with the surface of the vessel wall or highly backscattered luminal protrusion in continuity with the vessel wall and resulting in signal-free shadowing).

  3. Number of patients with cardiac death

    Time frame: 1 year, 3 years, and 5 years

    Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death.

  4. Number of patients with non-fatal spontaneous target-vessel myocardial infarction (excluding peri-procedural myocardial infarction)

    Time frame: 1 year, 3 years, and 5 years

    Any spontaneous myocardial infarction will be attributed to the target vessel if not clearly attributable to the non-target vessels.

  5. Number of patients with target lesion revascularization

    Time frame: 1 year, 3 years, and 5 years

    Any lesion revascularization will be considered in case of percutaneous coronary intervention or coronary artery bypass grafting of the studied lesion.

  6. Number of patients with restenosis or thrombosis of the target lesion

    Time frame: 1 year, 3 years, and 5 years

    Any revascularization procedure performed because of angiographic restenosis/thrombosis >50% at the site of the target lesion associated with clinical or objective evidence of inducible myocardial ischemia

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Definition of Intra-procedural Optical Coherence Tomography (OCT) Clinical Impact, Both in Terms of Revascularization Indication and Procedural Result.

Acronym: OCT-AGEM

Important dates

Study start
2025
Primary completion
2031
Study completion
2036
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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