Clinical Data › IMPERIAL Trial

IMPERIAL Trial

ELUVIA Drug-Eluting Vascular Stent System

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

Presented at LINC 2020

 

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 and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm

Baseline Characteristics

PATIENT DEMOGRAPHICS ELUVIA
(n=309)
Zilver PTX
(n=156)
Age (Years) 68.5±9.5 67.8±9.4
Male Gender 66.0% 66.7%
Diabetes Mellitus 41.7% 43.6%
History of Smoking 86.1% 84.0%
 
LESION CHARACTERISTICS ELUVIA
(n=309)
Zilver PTX
(n=156)
Target Lesion Length (mm) 86.5±36.9 81.8±37.3
Severely Calcified 40.1% 32.3%
Total Occlusions 31.2% 30.3%
Extending into Distal SFA 66.3% 65.4%
 
 

12-Month Results

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

Kaplan-Meier Primary Patency Rate: 12-Month Results chart
Clinically-Driven TLR Rate  |  12 Months
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).
Imperial Trials table
*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. Golzaar, 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.
 
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