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Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance

NCT07182799 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3200

Last updated 2025-09-19

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Enrico Romagnoli, MD, PhD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  • Francesco Burzotta, MD, PhD · Catholic University of the Sacred Heart

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2031-09-01
Completion
2036-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07182799 on ClinicalTrials.gov