Hear Principal Investigator, William Gray, MD review the IMPERIAL Trial 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 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
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%)
- 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)
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