Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry. (OROBICA)
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural, imaging, and economic outcomes of patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease.
Coronary artery calcification represents one of the main determinants of procedural complexity and adverse outcomes in contemporary interventional cardiology. Despite the increasing availability of advanced calcium-modification technologies and intracoronary imaging techniques, evidence regarding the optimal treatment strategy in real-world clinical practice remains limited, particularly among high-risk and complex patients often underrepresented in randomized trials.
The OROBICA Registry aims to systematically collect longitudinal data from all-comer patients treated for severely calcified coronary lesions using contemporary PCI strategies, including intracoronary imaging guidance (IVUS/OCT), rotational atherectomy, orbital atherectomy, intravascular lithotripsy, specialty balloons, and combined calcium-modification approaches.
The primary objective is to assess clinical and procedural outcomes, with particular focus on target vessel failure (TVF). Secondary and exploratory objectives include evaluation of procedural success, imaging findings, predictors of adverse outcomes, healthcare resource utilization, and economic impact associated with the treatment of calcified coronary lesions.
The registry is designed as a flexible research platform intended to support future hypothesis-generating analyses and provide real-world evidence to improve personalized management strategies for calcified coronary artery disease.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bergamo
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Bergamo, Bergamo, Italia, 24127
- Asst Papa Giovanni Xxiii
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Contacto:
- Francesco Moretti, MD
- Número de teléfono: +39 0352678249
- Correo electrónico: f.moretti@asst-pg23.it
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Contacto:
- Elena Zattoni, MSc
- Número de teléfono: +39 0352673452
- Correo electrónico: zattoni.elena@asst-pg23.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, angiographically defined as radiopacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall.
Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features:
- calcium arc ≥180°
- calcium thickness ≥0.3 mm
- calcium length ≥3 mm
- presence of calcified nodules
Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features:
- calcium arc ≥180°
- concentric or superficial calcium with extensive acoustic shadowing
- presence of calcified nodules
Exclusion Criteria:
- Lack of availability of essential clinical or procedural data.
- Refusal or withdrawal of informed consent for the prospective component of the registry, when applicable.
- Exercise of the right to object to data processing, according to applicable data protection regulations.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Imaging group
Patients undergoing intravascular imaging-guided PCI
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In this registry patients will undergo PCI of severely calcified coronary arteries
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Debulking group
Patients undergoing PCI with advanced calcium-modification devices
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In this registry patients will undergo PCI of severely calcified coronary arteries
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of Target Vessel Failure (TVF)
Periodo de tiempo: 1, 2 and 5 years
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Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization
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1, 2 and 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: 1, 2 and 5 years
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Defined as composite of all-cause death, myocardial infarction (MI), stroke, clinically-driven target vessel revascularisation (CD-TVR) and hospitalization for cardiovascular causes
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1, 2 and 5 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.
Periodo de tiempo: 30 days, 1, 2 and 5 years
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Evaluation of the incidence of Major Adverse Cardiovascular Events (MACE) and Target Lesion Revascularization (TLR) in relation to the specific calcium modification strategy used: rotational atherectomy, orbital atherectomy, intravascular lithotripsy (IVL), excimer laser, or combined strategies.
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30 days, 1, 2 and 5 years
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Total Procedural Costs and Healthcare Resource Utilization.
Periodo de tiempo: From index procedure up to 12 months.
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Assessment of total economic burden including costs of specific interventional materials/devices, total procedure duration, length of index hospital stay, and rate of all-cause hospital readmissions.
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From index procedure up to 12 months.
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Predictors of Severe Coronary Calcification and Procedural Complexity.
Periodo de tiempo: Baseline (at the time of index procedure).
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Identification of clinical, angiographic, intravascular imaging, and biochemical markers (e.g., renal function, calcium-phosphorus metabolism) associated with the presence of severe calcification and the requirement for advanced calcium modification tools.
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Baseline (at the time of index procedure).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francesco Moretti, MD, Papa Giovanni XXIII Hospital, Bergamo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Isquemia miocardica
- Enfermedad de la arteria coronaria
- Procedimientos quirúrgicos, operativo
- Procedimientos endovasculares
- Procedimientos quirúrgicos vasculares
- Procedimientos quirúrgicos cardiovasculares
- Procedimientos quirúrgicos mínimamente invasivos
- Intervención coronaria percutánea
Otros números de identificación del estudio
- OROBICA-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Ensayos clínicos sobre Intervención coronaria percutanea
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