NCT07182799

Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,200 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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)
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2031-09-01
• Completion: 2036-09-01
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: Italy