Eluvia™ Drug-Eluting Vascular Stent System
Eluvia™ Drug-Eluting Vascular Stent System

IMPERIAL Trial
1-Year Results

 

 

Eluvia demonstrated a statistically significant difference in primary patency and half the TLR rate vs. Zilver PTX at 12 months

 

12-month results from IMPERIAL, the world's first head-to-head DES SFA Trial1
Presented at LINC 2020

 

Kaplan-Meier Primary Patency Rate: 12-Month Results chart

CLINICAL-DRIVEN TLR RATE

In IMPERIAL RCT and as reported in The Lancet, 1-year ITT, CEC adjudicated mortality rates were 2.1% (6/292) for Eluvia and 4.0% (6/150) for Zilver PTX (p=0.23).
*Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
** Gray, WA TCT 2018.
† Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
1. IMPERIAL Trial: A 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. Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).

 

12-Month Remarkable and Consistent Results in Complex Lesions

12-moth Remarkable and Consistent Results in Complex Lesions
*Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
** Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
1. Intention to treat. Müller-Hülsbeck S, LINC 2019.
2. In IMPERIAL RCT, Eluvia K-M Primary Patency was 92.1% vs. 81.8% for Zilver PTX at 12 months.
3. Golzar, J. et al, Journal of Endovascular Therapy, Jan 2020. https://doi.org/10.1177/1526602820901723
4. In IMPERIAL Diabetic Subgroup, Eluvia K-M Primary Patency was 95.2% vs. 81.5% for Zilver PTX at 12 months. Diabetes = medically-treated diabetic patients.
5. PSVR < 2.0.
6. Moderate and severely calcified.
 

 

Better patient outcomes with Eluvia at a lower cost
based on comparison with Zilver PTX treatment

 
improve financial health.
  • Boston Scientific’s ELUVIA Drug-Eluting Stent and Coronary Paclitaxel-Eluting Stent Clinical Experience.
    Available at: https://www.fda.gov/media/128145/download [Accessed July 4 2019]Kbr/> Gray WA et al. Lancet. 2018 Oct 27;392(10157):1541-1551
    2-Year Results from IMPERIAL Trail; Presented at LINC 2020
 
Increase Operational Efficiencies
  • Boston Scientific’s ELUVIA Drug-Eluting Stent and Coronary Paclitaxel-Eluting Stent Clinical Experience.
    Available at: https://www.fda.gov/media/128145/download [Accessed July 4 2019]Kbr/> Gray WA et al. Lancet. 2018 Oct 27;392(10157):1541-1551
    2-Year Results from IMPERIAL Trail; Presented at LINC 2020
 

IMPERIAL Trial Overview

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
  • 5-year follow-up
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 mm and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm

Baseline Characteristics

Baseline Characteristics
Baseline Characteristics
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CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information not intended for use or distribution in France.
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