Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

RESOLUTE China Registry: (R-C Registry)

4 de abril de 2018 actualizado por: Medtronic Vascular

Evaluation of the Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in a Real-World Patient Population in China

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

Tipo de estudio

De observación

Inscripción (Actual)

1800

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

  • Porcelana
      • Beijing, Porcelana, 100000
        • Beijing Fumwai Hospital
      • Beijing, Porcelana, 100044
        • Peiking University People's Hospital
      • Fuzhou, Porcelana, 350001
        • Fujian Medical University Union Hospital
      • Guangdong, Porcelana, 510000
        • Guangdong Provincial People's Hospital
      • Nanjing, Porcelana, 210006
        • Nanjing First Hospital
      • Wuhan, Porcelana, 430022
        • Wuhan Asia Heart Hospital

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

18 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

Patients suitable for drug-eluting stent implantation according to the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the Resolute Zotarolimus-Eluting Coronary Stent System.

All consecutive patients eligible for drug-eluting stent implantation with the elective use of the Resolute stent in one or more target lesions are candidates to be enrolled.

Descripción

Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

  1. Age ≥ 18 years or minimum age as required by local regulations
  2. The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
  3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
  4. Intention to electively implant at least one Resolute stent
  5. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

  1. Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
  2. Women with known pregnancy or who are lactating
  3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
  5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
  6. Previous enrollment in the Resolute China Registry

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

  • Modelos observacionales: Solo caso
  • Perspectivas temporales: Futuro

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Target lesion failure (TLF)
Periodo de tiempo: 12m
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods at 1 year.
12m

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall stent thrombosis
Periodo de tiempo: 12m
Overall stent thrombosis, defined as definite and probable stent thrombosis, according to the Academic Research Consortium (ARC) definition, at 1 year.
12m
Device success, Lesion success, Procedural success
Periodo de tiempo: At the end of the index procedure or during hospital stay
At the end of the index procedure or during hospital stay
TLF
Periodo de tiempo: 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
Target lesion failure (TLF): a composite endpoint of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave) or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods will be assessed at 30 days, 6 months, 2 year, 3 year, 4 year and 5 year
30 days, 6 months, 2 year, 3 year, 4 year and 5 year
All deaths (cardiac, vascular and non-cardiovascular)
Periodo de tiempo: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Stent thrombosis rate
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
defined as definite, probable, possible, and overall stent thrombosis (according to ARC definition)
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Myocardial infarction
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Q wave and non-Q wave MI
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Revascularization
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
target lesion and target vessel revascularization (TLR and TVR)
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Significant bleeding complications and stroke
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
hemorrhagic in nature
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Target vessel failure (TVF)
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
Major adverse cardiac events (MACE)
Periodo de tiempo: at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year
a composite endpoint of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods
at 30 days, 6 months, 1 year, 2 year, 3 year, 4 year and 5 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Medtronic Vascular

Investigadores

  • Investigador principal: Jiyan Chen, MD, Guangdong Provincial People's Hospital
  • Investigador principal: Shubin Qiao, MD, Fu Wai Hospital, Beijing, China
  • Investigador principal: Lianglong Chen, MD, Fujian Medical University Union Hospital
  • Investigador principal: Shaoliang Chen, MD, The First Affiliated Hospital with Nanjing Medical University
  • Investigador principal: Weimin Wang, MD, Peiking University People's Hospital
  • Investigador principal: Guoying Zhu, MD, Wuhan Asia Heart Hospital

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.

Publicaciones Generales

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 (Actual)

1 de diciembre de 2010

Finalización primaria (Actual)

1 de abril de 2013

Finalización del estudio (Actual)

15 de diciembre de 2017

Fechas de registro del estudio

Enviado por primera vez

17 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

17 de noviembre de 2010

Publicado por primera vez (Estimar)

18 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de abril de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

4 de abril de 2018

Última verificación

1 de abril de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IP124

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 Enfermedades cardiovasculares

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Azerbaijan

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir