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

Objective

Evaluate the safety and effectiveness of the 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

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.

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

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.

24-Month Primary Patency Results

Eluvia demonstrated the highest ever 2-year primary patency1
1. Highest two-year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver  PTX RCT.
* Intention to treat. Kaplan-Meier estimate with standard errors. Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.

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%)

24-Month Safety Results*

  • 85.8% of Eluvia patients were free from Major Adverse Events at 24 months (vs. 79.9% of Zilver PTX patients)
  • All-cause mortality for Eluvia was 7.1% (21/295) vs. 8.3% (12/145) for Zilver PTX (p=0.6649)
* Intention to treat. Clinical Events Committee-adjudicated adverse events included major adverse events (MAE), all deaths, and stent thrombosis. MAEs defined as all causes of death through 1 month, target limb major amputation through 24 months, and target lesion revascularization through 24 months.