ELUVIA™

Drug-Eluting Vascular Stent System

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

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%)

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)
Product Overview

Product Overview

Advanced drug-eluting technology for PAD.

Button
Sustained Drug Release

Sustained Drug Release

Delivers paclitaxel when restenosis is most likely.

Button
Product Design

Product Design

Built on the proven InnovaTM Stent platform.

Button
Top