- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03745066
BioFreedom French Registry
A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Fontaine-lès-Dijon, Francia, 21121
- Clinique de Fontaine
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Haguenau Cedex, Francia, 67504
- Centre Hospitalier General
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Pessac, Francia, 33600
- Clinique Saint Martin
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Toulouse, Francia
- CHU Toulouse Rangeuil
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Cedex 2
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Clermont-ferrand, Cedex 2, Francia, 63050
- Clinique Des Dômes
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Essonne
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Quincy sous Sénart, Essonne, Francia, 91480
- at Hôpital Privé Claude Galien ICPS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients treated with one or more BioFreedom™ DCS .Patients who agree to comply with the follow up requirements. .Patients with a life expectancy of > 1 year at time of consent. .Patients eligible to receive dual anti platelet therapy (DAPT).
- Patients who have signed an Informed Consent
Exclusion Criteria:
- Patients unable or unwilling to give documented informed consent
- Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint .Patient has received an additional stent different from a BioFreedom™ DCS stent during the index procedure.
- Pregnant or breastfeeding women
- Planned surgery within 6 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for non HBR patients
- Planned surgery within 1 month of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri surgical period for HBR patients
- Patients under judicial protection, tutorship or curatorship
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 |
---|---|---|
DOCE
Periodo de tiempo: 1 year
|
Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR).
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
All-cause mortality
Periodo de tiempo: 12-month and 24-month
|
1. All-cause mortality, CD, non-cardiovascular and undetermined death in hospital and at 12 and 24 months
|
12-month and 24-month
|
Patient-oriented composite endpoint (POCE) at 12 and 24 months
Periodo de tiempo: 12 months and 2 years
|
Patient-oriented composite endpoint (POCE) at 12 and 24 months defined as all-cause mortality, any stroke, any MI (including nontarget vessel territory) and any revascularization.
|
12 months and 2 years
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Composite of Cardiovascular Death (CD) at 12 and 24 months
Periodo de tiempo: 12 months and 2 years
|
Composite of CD, MI and definite/probable stent thrombosis (ST) at 12 and 24 months.
|
12 months and 2 years
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Definite/probable ST at 12 and 24 months
Periodo de tiempo: 12 months and 24 months
|
Definite/probable ST at 12 and 24 months
|
12 months and 24 months
|
Target Vessel Failure defined at 12 and 24 months
Periodo de tiempo: 12 months and 24 months
|
Target Vessel Failure (TVF) defined as CD, target-vessel-related MI, and Target vessel revascularization (TVR) at 12 and 24 months
|
12 months and 24 months
|
Target Lesion Failure at 12 and 24 months
Periodo de tiempo: 12 months and 24 months
|
Target Lesion Failure (TLF) defined as CD, target-vessel-related MI, and clinically driven TLR at 12 and 24 months
|
12 months and 24 months
|
Clinically driven TLR at any follow-up time point
Periodo de tiempo: Inclusion, 12 months and 24 months
|
Clinically driven TLR at any follow-up time point
|
Inclusion, 12 months and 24 months
|
Clinically driven TVR at any follow-up time point
Periodo de tiempo: Inclusion, 12 months and 24 months
|
Clinically driven TVR at any follow-up time point
|
Inclusion, 12 months and 24 months
|
Any revascularization
Periodo de tiempo: within 24 months following the index procedure
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Any revascularization within 24 months following the index procedure, unless they are planned within the 1st month
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within 24 months following the index procedure
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Stroke, disabling and non-disabling.
Periodo de tiempo: Inclusion, 12 months and 24 months
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Stroke, disabling and non-disabling.
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Inclusion, 12 months and 24 months
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BARC 3 to 5 bleeding
Periodo de tiempo: Inclusion, 12 months and 24 months
|
BARC 3 to 5 bleeding
|
Inclusion, 12 months and 24 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Janusz Lipiecki, MD, Clinique Des Dômes
- Investigador principal: Philippe Garot, MD, ICPS, Massy
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 18-EU-01
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.
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. .