Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance (OCT-AGEM)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Stent implantation optimization; Diagnostic Test: Plaque vulnerability assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07182799

7262

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

3,200 participants in 2 patient groups

Non-interventional

Description:

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

Treatment:

Diagnostic Test: Plaque vulnerability assessment

Interventional

Description:

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

Treatment:

Diagnostic Test: Stent implantation optimization