- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01763476
Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions (ADCAT)
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%.
The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Bad Krozingen, Alemania, 79189
- Universitäts-Herzzentrum Freiburg-Bad Krozingen
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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:
- Subject must be between 50 and 85 years old
- Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
- Clinical diagnosis of symptomatic critical limb ischemia as defined by Rutherford 3, 4, or 5
- Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm;
- One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement
- The total length of target lesion(s) can be maximum 250 mm
- In total a maximum of 4 drug-coated balloons may be used to fully cover the target lesion
- Target vessel is 2.0 and 3.5 mm in diameter (visual estimate)
- Target lesion stenosis is >70% diameter stenosis (visual estimate)
- Guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomization
- Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures.
Exclusion Criteria:
- Significant (>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff;
- Angiographic evidence of thrombus within target vessel
- Thrombolysis within 72 hours prior to the index procedure
- In-Stent restenosis or restenosis of a native artery
- Aneurysm in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Recent myocardial infarction or stroke < 30 days prior to the index procedure
- Life expectancy less than 12 months
- Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent
- Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
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: Paclitaxel-coated balloon angioplasty
Target lesion to be treated with paclitaxel-coated balloon
|
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
|
Comparador activo: Atherectomy + paclitaxel-balloon
Target lesion to be treated with atherectomy (TurboHawk, ev3) and paclitaxel-coated balloon
|
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
primary patency
Periodo de tiempo: 6 months
|
Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4)
and angiography (core lab analysis).
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
target lesion revascularisation (TLR)
Periodo de tiempo: 6 and 12 months
|
Need for target lesion revascularisation from baseline to 6 months after index procedure.
|
6 and 12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Rutherford-Becker Class
Periodo de tiempo: 6 and 12 months
|
Change in Rutherford-Becker Class from Baseline to 6 and 12 months after index procedure
|
6 and 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Franz-Josef Neumann, M.D., Universitaets-Herzzentrum Freiburg-Bad Krozingen
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 (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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Aterosclerosis
- Enfermedades vasculares periféricas
- Enfermedad arterial periférica
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Paclitaxel
Otros números de identificación del estudio
- ADCAT(2)
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