ELUVIA™ Drug-Eluting Vascular Stent System Clinical Data and Resources
IMPERIAL Randomized Clinical Trial Full Cohort
Eluvia demonstrated a statistically significant difference in primary patency compared to Zilver PTX at 12 months in the IMPERIAL Trial.1
1. Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
Consistent results and proven benefits in patients at high risk for restenosis
IMPERIAL Severe/Moderate Calcium Subgroup Analysis
Eluvia demonstrated a 89.2% primary patency in severe and moderately calcified lesions.1,2
IMPERIAL Diabetic Subgroup Analysis
Eluvia demonstrated a statistically significant reduction in Target Lesion Revascularization (TLR) of greater than 70% in diabetic patients.