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Trials ; 14: 87, 2013 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-23537403

RESUMO

BACKGROUND: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm. METHODS/DESIGN: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention. DISCUSSION: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting. TRIAL REGISTRATION: ISRCTN47846578.


Assuntos
Angioplastia com Balão/instrumentação , Arteriopatias Oclusivas/terapia , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Paclitaxel/administração & dosagem , Projetos de Pesquisa , Stents , Dispositivos de Acesso Vascular , Ligas , Amputação Cirúrgica , Angiografia Digital , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Índice Tornozelo-Braço , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/mortalidade , Arteriopatias Oclusivas/fisiopatologia , Protocolos Clínicos , Constrição Patológica , Desenho de Equipamento , Falha de Equipamento , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Hemodinâmica , Humanos , Hiperplasia , Salvamento de Membro , Neointima , Países Baixos , Valor Preditivo dos Testes , Desenho de Prótese , Falha de Prótese , Recidiva , Resinas Vegetais , Método Simples-Cego , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla
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