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ACTIVE NOT RECRUITING
NCT07182799

Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3200

Start Date

2025-09-01

Completion Date

2036-09-01

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

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

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Rome, Italy