Express LD vascular stent in the treatment of iliac artery ... | 合法醫療器材資訊網

由LStockx著作·2010·被引用27次—Purpose:Toreportthe2-yearresultsoftheMELODIEtrial,whichevaluatedthesafetyandeffectivenessoftheballoon-expandableExpressLDVascularstentfor​ ...

Purpose: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease.

Methods: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years.

Results: The primary endpoint of 6-month mean percent luminal diameter lo...