Drug-Eluting Vascular Stent System
The Eluvia Drug-Eluting Stent System showed SUPERIOR results in the first head-to-head DES SFA Trial.
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).
IMPERIAL Trial Design
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.
- 465 (RCT) patients across 64 sites
- 5-year follow-up
- Primary patency, freedom from TLR, ankle-brachial index (ABI), Rutherford classification and stent fracture rate evaluated
- Safety: Major Adverse Events defined as all causes of death through 1 month, Target Limb Major Amputation through 12 months and/or Target Lesion Revascularization (TLR) through 12 months.
- Efficacy: Assess primary vessel patency* at 12 months post-procedure.
Key Eligibility Criteria
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA.
- Degree of stenosis ≥ 70% by visual angiographic assessment.
- Vessel diameter ≥ 4 and ≤ 6 mm
- Total lesion length ≥ 30 mm and ≤ 140 mm
12-Month Primary Patency Results
* Intention to treat. Kaplan-Meier estimate with standard errors. Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.
12-Month Safety Results
- 95.1% of Eluvia patients were free of Major Adverse Events at 12 months (vs. 91.0% of Zilver PTX patients)
- Eluvia demonstrated half the target lesion revascularization rate (TLR) of Zilver PTX at 12 months (4.5% vs. 9.0%)
24-Month Safety Results*
- 85.8% of Eluvia patients were free from Major Adverse Events at 24 months (vs. 79.9% of Zilver PTX patients)
- All-cause mortality for Eluvia was 7.1% (21/295) vs. 8.3% (12/145) for Zilver PTX (p=0.6649)