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Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Conditions
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)
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