- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01023919
Assessment of Surface Coverage of Two Types of DES in Diabetes Mellitus and Non- Diabetes Mellitus
Assessment of Surface Coverage of Polymer-based Sirolimus-eluting Stent( Cypher ) or Polymer-free Paclitaxel-eluting Stent (YinYi )in Diabetes Mellitus and Non- Diabetes Mellitus Patients by Optical Coherence Tomography
Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis. Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI) are poor in patients with DM compared with those without DM. Autopsy study has shown delayed neointimal healing with inadequate endothelialization and persistent stent surface fibrin deposition after DES implantation in DM patients. This might partially contribute to the high risk of late stent thrombosis.
YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with micro porous surface. However, limited data is available in vivo about the surface coverage after stent implantation in DM patients because of lack of sensitive imaging modalities. Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound(IVUS)that allows high-resolution tomographic intravascular imaging. Furthermore, several studies have demonstrated the feasibility of OCT to quantitatively evaluate the surface coverage and stent conditions in the follow up after PCI .
Therefore, the aim of this study was to analyze the surface coverage and late malapposition after two types of DES implantation in DM patients compared with non-DM patients by using OCT and IVUS
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Heilong jiang
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Harbin, Heilong jiang, Porcelana, 150081
- Reclutamiento
- The Second Affiliated Hospital of Harbin Medical University
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Contacto:
- Bo Yu, MD,PhD
- Número de teléfono: 86-0451-86605180
- Correo electrónico: yubodr@163.com
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Investigador principal:
- Bo Yu, MD, PhD
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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
General Inclusion Criteria:
- Age : 18-75Y
- Patients diagnosed as type 2 DM or non-DM.
Angiographic Inclusion Criteria:
- Patients were considered eligible if they have one significant (>70%) angiographic stenosis lesions in native coronary vessel by CAG.
- Each target is de novo lesion that can be treated with 1-2 stents.
- Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion Criteria
General Exclusion Criteria:
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
- Life expectancy <12 months due to another medical condition.
- Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus and paclitaxel or structurally related compounds.
- Creatinine level more than 2.0mg/dL or ESRD.
- Severe hepatic dysfunction (more than 3 times normal reference values).
- Planned surgery procedure≤12 months post-index procedure.
- Known allergy to stainless steel.
- Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
- Patient is not clinically appropriate for OCT evaluation in the opinion of investigator.
Angiographic Exclusion Criteria:
- Study lesion is ostial in location (within 3.0 mm of vessel origin).
- Study lesion involving arterial segments with highly tortuous anatomy.
- Complex lesion morphologies (bifurcation needs two stents technique, left main lesion, chronic obstructive occlusion, severe thrombus, heavy calcification).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Grupo A: MD
Enfermedad de las arterias coronarias con diabetes mellitus
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Cypher stent or YinYi stent randomly implanted in coronary artery disease
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Comparador activo: Group B: Non-DM
Coronary artery disease with diabetes mellitus
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Cypher stent or YinYi stent randomly implanted in coronary artery disease
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent)implantation
Periodo de tiempo: 6 months
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To investigate the difference of surface coverage pattern between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Periodo de tiempo: 12 months
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12 months
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To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Periodo de tiempo: 6 months
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6 months
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To investigate the incidence of malapposition between diabetic patients and non-diabetic patients after DES (Cypher stent or YINYI stent) implantation
Periodo de tiempo: 12 months
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12 months
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To investigate the differences of surface coverage pattern,the incidence of malapposition and in-stent thrombosis between Cypher stent and YINYI in diabetic patients
Periodo de tiempo: 6 and 12 months.
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6 and 12 months.
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To investigate the differences of surface coverage pattern,malapposition and the incidence of thrombosis between Cypher stent and YINYI in non-diabetic patients
Periodo de tiempo: 6 and 12 months.
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6 and 12 months.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedades del sistema endocrino
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- Diabetes mellitus
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antibacterianos
- Antibióticos, Antineoplásicos
- Agentes antifúngicos
- Paclitaxel
- Sirolimus
Otros números de identificación del estudio
- HMUOCT-DM vs NDM-2
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Device: Polymer-based sirolimus-eluting stent(Cypher stent ) and Polymer-free paclitaxel-eluting stent (YinYi stent)
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Harbin Medical UniversityDesconocidoDiabetes mellitus | Enfermedad coronariaPorcelana