ELUVIA Drug-Eluting Vascular Stent System
Hear Principal Investigator, William Gray, MD review the IMPERIAL Trial 12-Month Results
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 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
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%)
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