ELUVIA™ Drug-Eluting Vascular Stent System Clinical Data and Resources

Patient safety is at the core of our mission of advancing science for life. Data on the performance of the Eluvia stent has demonstrated highly consistent patency in patients with a number of major risk factors, including diabetes, occlusions, moderate and severe calcification and a history of smoking. We strive to learn about these patient differences and risk factors in our global, multi-center prospective study, the ongoing IMPERIAL trial.

IMPERIAL Randomized Clinical Trial Full Cohort

Kaplan-Meier Primary Patency Rate: 12-Month Results chart

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.

IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication.

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

89.2% Primary Patency: IMPERIAL Severe / Moderate Calcium Subgroup Analysis

IMPERIAL Severe/Moderate Calcium Subgroup Analysis

Eluvia demonstrated a 89.2% primary patency in severe and moderately calcified lesions.1,2

70% Reduction in TLR vs. Control: IMPERIAL Diabetic Subgroup Analysis

IMPERIAL Diabetic Subgroup Analysis

Eluvia demonstrated a statistically significant reduction in Target Lesion Revascularization (TLR) of greater than 70% in diabetic patients.

87.9% Primary Patency: IMPERIAL Long Lesion Substudy

IMPERIAL Long Lesion Sub-Study

Eluvia demonstrated a 87.9% primary patency in the IMPERIAL Long Lesion Sub-Study.1

  
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2. Versus 87.0% primary patency in the none/mild calcium arm of the IMPERIAL Calcium Subgroup.
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