- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00906022
Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND) (EXPAND)
EXPAND Study - Self Expanding Nitinol Stent Versus PTA With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication. A Prospective, Multi-center, Randomized Clinical Trail With Follow-up Investigations at 1, 3, 6, and 12 Months.
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months. Patients will be randomized either to treatment with stenting with the Astron Pulsar SE (4 or 5 mm diameter) stent or to PTA with optional bailout stenting in case of PTA failure.
The primary objective of this study is to show clinical improvement in the outcome of patients with symptomatic critical limb ischemia or severe intermittent claudication (Rutherford 3, 4, 5) treated with the Astron Pulsar SE (4 or 5 mm diameter) in comparison with PTA or optional bailout stenting in case of PTA failure.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 10365
- Gefässzentrum Berlin, Evangelisches Krankenhaus KEH
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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:
- Age > 50 years
- Patient has signed the patient informed consent.
- Patient is willing to adhere to the follow up time points and to follow the requirements during the study
- Patient has symptomatic critical limb ischemia or severe intermittent claudication classified as Rutherford category 3, 4 or 5.
- Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries below the radiographic level of the knee joint and above the level of the ankle (includes the peroneotibial trunk, anterior tibial artery, posterior tibial artery and peroneal artery, excludes the popliteal artery), as determined by pre-procedure intra-arterial DSA (preferred) or conventional angiography.
- Target (study) lesion to be treated is a de novo lesion (lesion ≤ 190 mm length). NOTE: Multiple or diffused lesion treatment is allowed as long as total lesion length ≤ 190 mm)
- Reference vessel diameter is between 2.5 and 4.0 mm.
- Target vessel: It must be possible to follow the vessel run-off to the foot and/or the wound area. NOTE: Patients with incomplete or abnormal anatomical run-off are NOT excluded. Important is to see that the there is a run-off to the foot and/or wound area even if collaterals are involved.
- Haemodynamically significant inflow stenoses of vessels above the knee were successfully treated before.
- Lesions must be crossed successfully with a guide wire and guide wire must be within the true lumen of the distal vessel.
Notes:
- Target vessel has to be defined; Target vessel = vessel with target lesion to be treated
- Target vessel: Multiple or diffused lesions with total length > 190 mm => inclusion criteria are NOT fulfilled
- NON-target vessel(s): haemodynamically significant lesion can be treated according to investigator's discretion
Exclusion Criteria:
- Patient refuses treatment.
- Patient is legally, physically or mentally unable to give consent.
- ABI / TBI measurement is impossible.
- Target lesion is pre-treated.
- Target lesion lies within or adjacent to an aneurysm.
- Acute thrombus present in the target limb.
- The reference vessel diameter is not suitable for available stent size (RVD < 2.5 and > 4.0 mm).
- Length of lesion requires more than one treatment device (lesion length > 190 mm)
- Hybrid technique (bypass surgery and peripheral intervention with PTA or stent during the same session) is not allowed. Note: Allowed is if the patient got a P1 or P3 bypass in a previous session and it is possible to treat a distal lesion through that bypass in a separate session. Time window between bypass surgery and planned intervention must be at least 30 days.
- Life-expectancy less than 12 months at the time of screening.
- Patient has a known allergy to heparin, aspirin, clopidogrel or other anticoagulant/ antiplatelet therapies, to nickel or contrast media or is unwilling to tolerate such therapies.
- Patient has bleeding diatheses
- Patient is currently enrolled in another investigational device or drug trial.
- Patient took part in another investigational device or drug trial within 3 months prior to screening.
- Patient is currently breast-feeding, pregnant or intends to become pregnant.
- Myocardial infarction without coronary revascularization < 6 months prior to screening and with coronary revascularization < 1 month prior to screening.
- Previous coronary or peripheral bypass surgery within 30 days prior to screening.
- Patient had a calculated creatinine clearance < 30 ml/min within 30 days prior to screening.
- Patient had a stroke or TIA within the last 6 months prior to screening.
- Patient had a major amputation of the target limb (defined as above the ankle) at the time of screening
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 |
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Experimental: Astron Pulsar Stent
Device: Astron Pulsar Stent
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Stenting with Astron Pulsar
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Comparador activo: PTA alone
Device: Balloon angioplasty alone
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Balloon angioplasty alone
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale.
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
MAE rate, amputation rate, mortality rate, Maximum Walking Distance and Pain Free Walking Distance, Quality of Life, Binary restenosis rate, technical and device success, hemodynamic outcome
Periodo de tiempo: 6 and 12 months
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6 and 12 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- C0801
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 Severe Intermittent Claudication
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Fundacion PodoactivaTerminadoEnfermedad de Sever | Apofisitis del calcáneoEspaña
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University of DelawareReclutamientoEnfermedad de Sever | Tendinopatía de Aquiles | Tendinopatía insercional de Aquiles | Apofisitis; calcáneoEstados Unidos
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Ann & Robert H Lurie Children's Hospital of ChicagoAmerican Medical Society for Sports MedicineDesconocidoSíndrome de Osgood-Schlatter | Síndrome de Sinding-Larsen y Johansson | Enfermedad de Sever | ApofisitisEstados Unidos
Ensayos clínicos sobre Astron Pulsar Stent
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Biotronik, Inc.TerminadoEnfermedad vascular periférica | Enfermedad Arterial PeriféricaCanadá, Estados Unidos
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Flanders Medical Research ProgramTerminadoEnfermedad vascular periférica | ClaudicaciónBélgica, Alemania
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Medical University of ViennaDesconocidoReestenosis del stent | Hiperplasia íntimaAustria
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Fundacion para la Formacion e Investigacion Sanitarias...Aún no reclutando
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Flanders Medical Research ProgramTerminadoEnfermedad vascular periféricaBélgica
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University of California, Los AngelesTiny Blue Dot Foundation; The Dana FoundationTerminadoLesiones Cerebrales | Trastornos de la concienciaEstados Unidos
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Vienna General HospitalTerminadoEnfermedades vasculares periféricas | Claudicación intermitente | AngioplastiaAustria
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Massachusetts General HospitalRetiradoPulsariones de ultrasonido de baja intensidad
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Massachusetts General HospitalActivo, no reclutando