OVERVIEW
DRUG-ELUTING TECHNOLOGY
CLINICAL DATA
ELUVIA
OVERVIEW
DRUG-ELUTING TECHNOLOGY
CLINICAL DATA
ELUVIA
 
Watch the Video

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

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
  • Primary Endpoints:

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.

  • Primary patency, freedom from TLR, ankle-brachial index (ABI), Rutherford classification and stent fracture rate evaluated
  • Eligible patients with chronic, symptomatic (Rutherford categories 2, 3 or 4) lower limb ischemia and stenotic, restenotic or occlusive lesions in the native superficial femoral artery or proximal popliteal artery
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 mm and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm
  • 5-year follow-up

Baseline Characteristics

Patient Demographics
Lesion Characteristics
 
Kaplan-Meier Primary Patency Rates: 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

Rutherford Category

 

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