RESUMO
PURPOSE: To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). METHODS: Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. RESULTS: In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. CONCLUSION: The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.
Assuntos
Ligas , Arteriopatias Oclusivas/terapia , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Artéria Poplítea , Stents , Idoso , Arteriopatias Oclusivas/complicações , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/fisiopatologia , Distribuição de Qui-Quadrado , Chile , Constrição Patológica , Intervalo Livre de Doença , Procedimentos Endovasculares/efeitos adversos , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/etiologia , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico , Isquemia/etiologia , Isquemia/fisiopatologia , Israel , Tábuas de Vida , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Radiografia , Recidiva , Sistema de Registros , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularAssuntos
Aneurisma Intracraniano/etiologia , Malformações Arteriovenosas Intracranianas/complicações , Adulto , Corantes , Dislexia/etiologia , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Verde de Indocianina , Aneurisma Intracraniano/cirurgia , Malformações Arteriovenosas Intracranianas/cirurgia , Imageamento por Ressonância Magnética , Procedimentos Neurocirúrgicos , Convulsões/etiologia , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
Endovascular treatment for a wide-neck anterior communicating artery (AcomA) aneurysm remains technically challenging. Stent-assisted embolization has been proposed as an alternative of treatment of complex aneurysms. The X-configuration double-stent-assisted technique was used to achieve successful coiling of wide-neck AcomA aneurysm. Implanted stent can alter intra-arterial flow. Follow-up angiograms 4 months later showed flow changes due to used X-technique of stents implantation and filling of the anterior cerebral artery from the opposite internal carotid artery.
