- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00235118
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10029
- Mt. Sinai Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Anatomic (stent-graft)
Aortic Aneurysm Diameter
- > 4.5 cm
- Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
- Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms < 3.0 cm.
- Saccular aortic aneurysms > 3.0 cm.
Aortic Neck
- Diameter > 17 mm and < 28 mm (Phase I)
- Diameter > 14 mm and < 28 mm (Phase II)
Angulation Neck Length < 45° > 15 mm <60° > 25 mm
Iliac Arteries
- Diameter > 8 mm and < 18 mm (Phase I and Phase II)
- At least one common iliac artery with a cuff > 15 mm.
Diameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm
*NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).
Anatomic (surgical controls)
· Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria.
Aortic Aneurysm Diameter
- > 4.5 cm
- Those aortic aneurysms <4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
- Aorto-iliac aneurysm in which the aortic aneurysm is <4.5 cm but the iliac artery aneurysm are >3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms <3.0 cm.
- Saccular aortic aneurysms > 3.0 cm.
- Clinical (stent-graft)
- Males and non-pregnant females > 40 years of age.
- Clinical (surgical controls)
Surgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria.
Exclusion Criteria:
Anatomic (stent-graft)
Aortic Aneurysm Diameter
· < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
Aorto-iliac Aneurysms
- < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
- The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device.
Aortic Neck
- Diameter < 17 mm and > 28 mm (Phase I)
- Diameter < 14 and >28 (Phase II)
- Thrombus lined
Highly calcified
- NOTE: See inclusion criteria for length below the renals and degree of angulation.
Iliac Arteries
- < 8 mm and > 18 mm (native) (Phase I and Phase II)
- Highly calcified (common)
Neither common iliac artery with a cuff > 15 mm.
- NOTE: See inclusion criteria for aortic neck and iliac artery diameters.
Anatomic (surgical controls)
· Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria.
Aortic Aneurysm Diameter
· < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
Aorto-Iliac Aneurysms
- < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
- The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries.
Clinical (stent-graft)
- Ruptured abdominal aortic aneurysm.
- Renal insufficiency - creatinine level > 2.5 mg/dl.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
---|
Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.
|
The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.
|
Medidas de resultado secundarias
Medida de resultado |
---|
· Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.
|
·
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Marin, MD, Mount Sinai Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P98-4601
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 Aneurisma aórtico abdominal
-
Laser and Skin Surgery Center of New YorkZeltiq AestheticsTerminadoGrasa abdominal | Tejido Adiposo AbdominalEstados Unidos
-
Meccellis BiotechReclutamientoHernia abdominal | Defecto de la pared abdominal | Lesión de la pared abdominalFrancia
-
Joanne TurnerAún no reclutandoCirugía abdominal | Hernia abdominal
-
Spital Limmattal SchlierenTerminado
-
Assistance Publique - Hôpitaux de ParisDesconocidoAneurisma aórtico abdominal pequeño | Aneurisma aórtico abdominal,Francia
-
EndologixActivo, no reclutando1 Aneurisma de aorta abdominal paravisceral | 2 Aneurisma aórtico abdominal yuxtarrenal | 3 Aneurisma aórtico abdominal pararrenal | 4 Aneurismas aórticos abdominales complejosEstados Unidos
-
University of Sao Paulo General HospitalTerminadoDefecto de la pared abdominal | Infección | Hernia de la pared abdominal | Fístula de la pared abdominal | Infección de la pared abdominalBrasil
-
Unity Health TorontoReclutamientoPeritonitis | Absceso Abdominal | Lesiones Abdominales | Trauma abdominal | Sepsis Abdominal | Aneurisma Abdominal | Síndrome Compartimental Abdominal | Infección AbdominalCanadá
-
Datascope Corp.DesconocidoEnfermedad aneurismática de la aorta abdominal | Enfermedad oclusiva de la aorta abdominalFrancia
-
Assiut UniversityDesconocidoTrauma Abdominal Penetrante
Ensayos clínicos sobre Cordis AAA Bilateral Device
-
Cordis CorporationTerminadoAneurismas aórticos abdominalesAlemania