Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography (NeoCover)
Evaluation of Neointimal Coverage of Everolimus-Eluting Stent and Bare-metal Stent After Implantation in STEMI Patients by Optical Coherence Tomography
Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.
However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- The Second Affiliated Hospital of Harbin Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age: 18-75 years
- Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
- Length of culprit lesion≤25mm.
- Vessel size in between 2.5 and 4.0 mm.
- Signed patient informed consent.
Exclusion Criteria:
- Prior administration of thrombolytic therapy.
- Cardiogenic shock.
- Renal failure (Crea≥2.0mg/dL).
- Recent major bleeding.
- Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
- Left main disease
- Multi-vessel lesion
- Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
- Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
- No suitable anatomy for OCT scan.
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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Comparador activo: DES
Everolimus-Eluting Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
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Comparador activo: BMS
Bare-Metal Stent implanted in patients with ST-segment elevation myocardial infarction (STEMI)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by frequency domain optical coherence tomography (FD-OCT).
Periodo de tiempo: 3-month
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The covered strut is defined as the strut has definite neointimal over it.
And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
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3-month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of the rate of covered struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Periodo de tiempo: 12-month
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The covered strut is defined as the strut has definite neointimal over it.
And the rate of covered struts was calculated as the number of covered struts divided the number of total struts.
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12-month
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Comparison of the rate of malaposed struts to EES vs BMS implanted in STEMI patients by FD-OCT.
Periodo de tiempo: 3-month
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Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS.
The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
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3-month
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Comparison of the rate of malaposed struts to the EES vs BMS implanted in STEMI patients by FD-OCT.
Periodo de tiempo: 12-month
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Strut malapposition is defined as struts detached from the vessel wall > 108μm for EES and > 101μm for BMS.
The rate of malaposed struts is calculated as the number of malaposed struts divided the number of total struts.
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12-month
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Major adverse cardiovascular events (MACE)
Periodo de tiempo: 12-month
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12-month
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- HMUOCT-STEMI
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