Express SD features a patented Tandem Architecture™ Stent Design
Macro™ Elements and additional proximal connectors engineered to provide strength, especially in ostial lesions
Micro™ Elements designed to provide flexibility during stent placement
Clinical Information
RENAISSANCE Clinical Trial
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%.
OutcomesPrimary 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.