Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention (CT-PLAN-PCI)
Coronary Computed Tomography Angiography (CCTA) for the Pre-procedural Planning of Percutaneous Coronary Intervention: A Randomized Trial of Routine PCI Versus CCTA-guided PCI
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
CCTA provides comprehensive anatomical characterization of coronary arteries, including plaque morphology. It allows assessment of the origin and course of the coronaries, proximal and distal reference vessel dimensions, which can inform landing zones for stent length selection, and stent sizing. CCTA also enables comprehensive physiological assessment through fractional flow reserve (FFRCT), including FFRCT pullback for disease pattern characterization and delta FFRCT. In addition, CCTA can estimate vessel-specific myocardial mass to support bifurcation PCI planning and may assist intra-procedural guidance through CT co-registration. Whether CCTA-guided PCI is non-inferior to an intravascular ultrasound (IVUS) guided PCI strategy is being evaluated in the Precise Procedural and PCI Plan (P4) randomized clinical trial (NCT05253677). P4 enrolled approximately 1,100 patients and is evaluating the incidence of major adverse cardiovascular events (cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization) between CT- and IVUS-guided PCI at 12-months. While this landmark trial is expected to provide the first randomized data to support CT-guided PCI, broader clinical adoption remains limited by the need for multiple software platforms and investigational applications.
While promising, there are limited prospective and/or randomized data showing that CT-guided PCI is superior to standard of care. Early U.S. experience using coronary computed tomography angiography (CCTA) for percutaneous coronary intervention (PCI) planning highlighted the emerging role of CCTA to inform case complexity, equipment utilization, lesion morphology and non-invasive coronary physiology. Despite these promising findings, these studies were small, single-center, and non-controlled. To demonstrate clinical value, a randomized controlled trial comparing CCTA guided PCI with standard PCI would be necessary to determine whether this approach yields similar or superior outcomes in broader patient populations.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55407
- Minneapolis Heart Institute Foundation
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Investigador principal:
- Yader Sandoval, MD
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Contacto:
- Olga Mastrodemos
- Número de teléfono: 612-863-4768
- Correo electrónico: olga.mastrodemos@allina.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- At least one moderate-severe coronary stenosis on CCTA with an FFRCT ≤0.80 involving no more than two vessels (i.e. target lesion(s) must be FFRCT eligible)
- Referral for non-emergent PCI of at least one de novo stenosis in a native coronary artery with a reference diameter ≥2 mm on CCTA.
Exclusion Criteria:
- Multivessel CAD involving ≥3 vessels.
- Severe left main disease >50%
- Prior CABG
- Prior PCI in target vessel
- Planned CABG
- Chronic coronary total occlusion in the target vessel
- ST-elevation myocardial infarction
- Emergent PCI
- Cardiac arrest
- Cardiogenic shock
- Scenarios where FFRCT is not possible: inadequate CCTA quality for FFRCT, small vessels <2 mm, with stents at the target vessel.
- Unstable high-risk NSTE-ACS (hemodynamic instability, refractory angina, unstable arrhythmias, persistent ischemia).
- Patients who are pregnant or nursing or plan to be pregnant in the period up to 2 years following the index procedure will not be approached due to exposure to fluoroscopy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CT-guided PCI
Pre-procedural planning will be completed using the participant's CT, and tools including Heartflow's PCI Navigator
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Participants randomized to CT-guided PCI will have their clinically available CCTAs analyzed using commercially available software to create a pre-procedural plan, which will be used to help guide the procedure
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Comparador activo: Routine PCI
Participants randomized to this arm will undergo standard-of-care PCI without pre-procedural planning based on CT
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Participants randomized to routine PCI will not have their CCTA's analyzed pre-procedure.
The investigator may use intravascular imaging and pre-PCI FFR, but these are not mandated.
The investigator will use the information obtained from the coronary angiogram to treat any coronary artery disease that is present.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Procedural time
Periodo de tiempo: intra-procedural
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procedural time, defined as the time between the first to the final angiographic image acquisition
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intra-procedural
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Contrast volume
Periodo de tiempo: intra-procedural
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The volume of contrast used during the index procedure
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intra-procedural
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Radiation dose
Periodo de tiempo: intra-procedural
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The dose of radiation used during the index procedure
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intra-procedural
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Fluoroscopy time
Periodo de tiempo: intra-procedural
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The amount of time during the procedure that fluoroscopy was used
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intra-procedural
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Post-PCI pressure wire based FFR
Periodo de tiempo: intra-procedural
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Measured as a blinded investigational endpoint after the final angiographic image and not included in procedural time
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intra-procedural
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Use of advanced calcium modification techniques
Periodo de tiempo: intra-procedural
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intra-procedural
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Resource utilization
Periodo de tiempo: intra-procedural
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number of diagnostic or guide catheters used, equipment usage throughout the case
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intra-procedural
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PCI Complications and Incidence of MACE During Index Procedure
Periodo de tiempo: intra-procedural
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incidence of major adverse cardiac events during the index procedure
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intra-procedural
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Peri-procedural myocardial injury and infarction
Periodo de tiempo: Peri-procedural
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Incidence of myocardial injury and infarction after the index procedure, during hospitalization
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Peri-procedural
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Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2436925-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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