Express™ SD Renal and Biliary Premounted Stent System ... | 合法醫療器材資訊網

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Overview The RENAISSANCE Trial was a prospective, multi-center, single arm study designed to evaluate the Express SD Renal Premounted Stent System in the treatment of atherosclerotic lesions in the aortorenal ostium.

The primary objective was to demonstrate superiority of the duplex triggered, angiographically-confirmed binary restenosis rate at 9-months over the 40% pre-specified Objective Performance Criterion (OPC) representative of PTRA. 

Trial Design The RENAISSANCE Trial enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions ≤15mm long in vessels between 4.0 and 7.0mm diameter with diameter stenosis ≥70%. 

Outcomes Primary Endpoint: 21.3% binary in-stent restenosis rate at 9-months, defined as the proportion of target lesions with ≥50% diameter stenosis based on angiographic core lab assessment.