Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

Active, not recruitingOBSERVATIONAL
Enrollment

3,200

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 1, 2031

Study Completion Date

September 1, 2036

Conditions
Acute Coronary Syndromes (ACS)Chronic Coronary SyndromeMINOCAINOCA (Ischemia With Non Obstructive Coronary Artery Disease)Percutaneous Coronary Intervention (PCI)Coronary Stent ImplantationStent RestenosisStent ThrombosisClinical Outcome
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

Trial Locations (1)

00168

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER