Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

NCT ID: NCT07182799

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2036-09-01

Brief Summary

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.

Detailed Description

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

Conditions

Acute Coronary Syndromes (ACS); Chronic Coronary Syndrome; MINOCA; INOCA (Ischemia With Non Obstructive Coronary Artery Disease); Percutaneous Coronary Intervention (PCI); Coronary Stent Implantation; Stent Restenosis; Stent Thrombosis; Clinical Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Non-interventional

Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, resulting in a non-obstructive coronary artery disease

Plaque vulnerability assessment

Intervention Type: 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)

Interventional

Patients undergoing an OCT coronary assessment during a clinically indicated coronary angiogram, guiding a percutaneous coronary intervention

Stent implantation optimization

Intervention Type: 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

Interventions

Plaque vulnerability assessment

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)

Intervention Type: DIAGNOSTIC_TEST

Stent implantation optimization

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention 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); 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)

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Romagnoli Enrico

Clinical Physician, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Romagnoli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Francesco Burzotta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, , Italy

Countries

Italy

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

7262

Identifier Type: -

Identifier Source: org_study_id