Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents
11 de marzo de 2019 actualizado por: Yonsei University
Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study
This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion .
The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography.
After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry.
However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible.
Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress.
To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.
Tipo de estudio
De observación
Inscripción (Anticipado)
894
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Seoul, Corea, república de, 120-752
- Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Participants who already enrolled in DETECT-OCT
Descripción
Inclusion Criteria:
- 1. patients who were enrolled in the previous DETECT-OCT study
- 2. Patients who agreed with informed consents
Exclusion Criteria:
- 1. Patients who disagreed with informed consents
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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OCT-guided group
OCT-guided PCI with EES or BES
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Angiography-guidance group
Angio-guided PCI with EES or BES
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall survival
Periodo de tiempo: At 5 years
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Free from death
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At 5 years
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Overall survival
Periodo de tiempo: At 10 years
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Free from death
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At 10 years
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Cardiac death
Periodo de tiempo: At 5 years
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Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
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At 5 years
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Cardiac death
Periodo de tiempo: At 10 years
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Within 30 days after intervention, deaths due to myocardial infarction, cardiac perforation, tamponade or arrhythmia or death associated with intervention, death due to complications of intervention, and major cardiovascular deaths that can not be ruled out by a judgment of the screening adverse reaction review committee.
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At 10 years
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Myocardial infarction
Periodo de tiempo: At 5 years
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(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis.
The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI.
Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
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At 5 years
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Myocardial infarction
Periodo de tiempo: At 10 years
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(Non-Q-wave and Q-wave) due to occlusion of the target lesion or severe restenosis.
The criteria for classification and diagnosis of myocardial infarction follow the Academic Research Consortium and the Third Universal Definition of MI.
Coronary intervention Clinically significant myocardial infarction following the procedure has recently been defined by the Society for Cardiovascular Angiography and Interventions (SCAI)
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At 10 years
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Target lesion revascularization
Periodo de tiempo: At 5 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion.
The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
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At 5 years
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Target lesion revascularization
Periodo de tiempo: At 10 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target lesion due to restenosis or other complications of the target lesion.
The target lesion is defined as a treated segment of the vessel, ranging from 5 mm in the proximal portion of the stent to 5 mm in the distal portion of the stent.
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At 10 years
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Target vessel revascularization
Periodo de tiempo: At 5 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
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At 5 years
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Target vessel revascularization
Periodo de tiempo: At 10 years
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Repeatedly performing percutaneous intervention or target bypass repeatedly to the target vessel due to restenosis or other complications of the target vessel.
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At 10 years
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Stent thrombosis
Periodo de tiempo: At 5 years
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Based on the Academic Research Consortium (ARC) definition.
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At 5 years
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Stent thrombosis
Periodo de tiempo: At 10 years
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Based on the Academic Research Consortium (ARC) definition.
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At 10 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de abril de 2019
Finalización primaria (Anticipado)
1 de octubre de 2026
Finalización del estudio (Anticipado)
1 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2019
Primero enviado que cumplió con los criterios de control de calidad
11 de marzo de 2019
Publicado por primera vez (Actual)
13 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
11 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 4-2018-1167
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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