Eluvia Drug-Eluting Vascular Stent

 

Ranger Paclitaxel-Coated PTA Balloon Catheter

 
 
Watch the Video

Hear Principal Investigator, William Gray, MD review the IMPERIAL Trial Results

12-month results from IMPERIAL, the world's first head-to-head DES SFA Trial1

Presented at LINC 2020

 

Objective

Evaluate the safety and effectiveness of the Boston Scientific Corporation ELUVIA™ Drug-Eluting Vascular Stent System for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.

 

IMPERIAL Trial Design

Global multi-center, 2:1 randomization against Cook Medical’s Zilver™ PTX™ Stent, controlled, single-blind, non-inferiority trial; core lab adjudicated.

  • 465 (RCT) patients across 64 sites
  • 5-year follow-up
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm

Baseline Characteristics

Patient Demographics
Lesion Characteristics
 
Kaplan-Meier Primary Patency Rate: 12-Month Results chart

 

12-Month Primary Patency Results

Eluvia demonstrated a statistically significant difference in primary patency compared to Zilver PTX at 12 months in the IMPERIAL Trial.

 

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%)

 

Clinically-Driven TLR Rate  |  12 Months<br /><span style="font-size: 13px;">Gray, W. Presented at TCT 2018. TLR = Target Lesion Revascularization.</span>

Patient Outcomes

  • 85.8% of Eluvia patients presented with no or minimal claudication (Rutherford 0-1) at 12 months (vs. 84.5% of Zilver PTX patients)
  • 89.6% of Eluvia patients had improvement by at least 1 Rutherford category compared with baseline without the need for TLR (vs. 83.1% of Zilver PTX patients)
Clinically-Driven TLR Rate  |  12 Months
 
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