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- Ensayo clínico NCT03522038
Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.
The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 and ≤80
- Patients diagnosed with CTO by coronary angiography
- Patient planned to receive PCI
- Diameter of CTO vessel > 2.25 mm
Exclusion Criteria:
- Age >80 or <18
- Myocardial infarction with 1 months
- Inability to give informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline FFR at 6 months after CTO PCI
Periodo de tiempo: At baseline and 6 months after CTO PCI
|
FFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
FFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The FFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline FFR at 6 months after CTO PCI
Periodo de tiempo: At baseline and 6 months after CTO PCI
|
CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline Myocardial perfusion at 6 months after CTO PCI
Periodo de tiempo: At baseline and 6 months after CTO PCI
|
The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline Myocardial Viability at 6 months after CTO PCI
Periodo de tiempo: At baseline and 6 months after CTO PCI
|
The myocardial viability before and after CTO PCI was evaluated by PET-MRI.
|
At baseline and 6 months after CTO PCI
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
MACE
Periodo de tiempo: 6 months after CTO PCI
|
A major adverse cardiac event (MACE) was defined as the occurrence of cardiac death, nonfatal MI, and target lesion revascularization during the follow-up period.
|
6 months after CTO PCI
|
In-stent restenosis
Periodo de tiempo: 6 months after CTO PCI
|
In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.
|
6 months after CTO PCI
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- ZS-CV-201801
Plan de datos de participantes individuales (IPD)
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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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