- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01331473
PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)
PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Primary Objective:
The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection.
Secondary Objective:
Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Panagiotis Papanagiotou, MD
- Número de teléfono: 24302 +49684116
- Correo electrónico: provenon.study@me.com
Copia de seguridad de contactos de estudio
- Nombre: Christian Roth, MD
- Número de teléfono: 24302 +49684116
- Correo electrónico: provenon.study@me.com
Ubicaciones de estudio
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Saarland
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Homburg, Saarland, Alemania, 66424
- Reclutamiento
- Department of Diagnostic and Interventional Neuroradiology
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Sub-Investigador:
- Christian Roth, MD
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Contacto:
- Panagiotis Papanagiotou, MD
- Número de teléfono: 24302 49684116
- Correo electrónico: provenon.study@me.com
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Contacto:
- Christian Roth, MD
- Número de teléfono: 24302 49684116
- Correo electrónico: provenon.study@me.com
-
Investigador principal:
- Wolfgang Reith, MD
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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:
- Male and female ≥ 18 years old;
- Suitable/Eligible for carotid artery revascularization;
- Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
- Adequate clinical conditions to perform DW-MRI.
- Ability of the individual to understand the character and the consequences of clinical trial.
- Signed and dated informed consent provided before the beginning of any intervention.
- Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.
Exclusion Criteria:
- Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
- Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry).
- Intracranial mass lesion (i.e., abscess, tumor, or other infection).
- peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
- Lactation.
- Arterio-venous malformation in the territory of the target carotid artery.
- Any disease or medication that affects local hemostasis,
- Participation in other clinical trials during the present clinical trial or within the last month.
- Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
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 |
---|---|
Comparador activo: Carotid Artery Stenting without Protection
Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device
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Carotid artery angioplasty and stenting without cerebral embolic protection
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Comparador activo: Carotid Artery Stenting with Proximal Protection
Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and with a proximal embolic protection device provided by the GORE Neuro Protection System
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Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
Periodo de tiempo: Day 1-3
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Day 1-3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
Periodo de tiempo: Day 30
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Day 30
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Technical Success of the procedure
Periodo de tiempo: Day 0
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Subjects (both groups) who due to technical reaseons are unable to performe carotid artery stenting will be considered as technical failures. Subjects who are unable to tolerate flow reversal (in group 2) and have their procedures completed without embolic protection or other methods will be also considered as technical failures. |
Day 0
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Access site vascular complications, defined as need for surgical repair or blood transfusion
Periodo de tiempo: Day 0-7
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Day 0-7
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Wolfgang Reith, MD, Saarland University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Grunwald IQ, Papanagiotou P, Roth C, Fassbender K, Karp K, Krick C, Schieber H, Muller M, Haass A, Reith W. Lesion load in unprotected carotid artery stenting. Neuroradiology. 2009 May;51(5):313-7. doi: 10.1007/s00234-008-0491-6. Epub 2009 Feb 6.
- Grunwald IQ, Papanagiotou P, Struffert T, Politi M, Krick C, Romaike BF, Ahlhelm F, Reith W. Reversal of flow during carotid artery stenting: use of the Parodi antiembolism system. Neuroradiology. 2007 Mar;49(3):237-41. doi: 10.1007/s00234-006-0178-9. Epub 2007 Jan 5.
- Kastrup A, Nagele T, Groschel K, Schmidt F, Vogler E, Schulz J, Ernemann U. Incidence of new brain lesions after carotid stenting with and without cerebral protection. Stroke. 2006 Sep;37(9):2312-6. doi: 10.1161/01.STR.0000236492.86303.85. Epub 2006 Aug 3.
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
Otros números de identificación del estudio
- PROVENON01
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