IMPERIAL Severe/Moderate Calcium Subgroup Analysis

12-Month Primary Patency Results1

89.2% primary patency in severe and moderately calcified lesions2

1. 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.

2. Versus 87.0% primary patency in the none/mild calcium arm of the IMPERIAL Calcium Subgroup. 

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

IMPERIAL Trial RCT Full Cohort

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12-Month Primary Patency Results3

Eluvia demonstrated a statistically significant difference in primary patency compared to Zilver PTX at 12 months in the IMPERIAL Trial.

3. 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.

IMPERIAL Diabetic Subgroup Analysis

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12-Month Safety Results

Eluvia demonstrated a statistically significant reduction in TLR of greater than 70% in diabetic patients.

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

IMPERIAL Long Lesion Sub-Study

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12-Month Primary Patency Results4

Eluvia demonstrated a 87.9% primary patency in the IMPERIAL Long Lesion Sub-Study.

4. 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.

IMPERIAL Clinical Trials
Eluvia has demonstrated clinical benefit of low TLR rates and no mortality signal
Eluvia Platform Mortality Data
  ELUVIA Drug-Eluting Stent INNOVA Bare Metal Stent
Mortality IMPERIAL RCT
(n = 309)
MAJESTIC
(n = 57)
SuperNOVA
(n = 299)
All-cause 2.0% (6/301) at 1 year 3.6% (2/55) at 3 years 7.9% (21/265) at 3 years
Cardiac 1.0% (3/301) at 1 year 1.8% (1/55) at 3 years 4.2% (11/265) at 3 years
 
Eluvia Platform TLR Data
  ELUVIA Drug-Eluting Stent INNOVA Bare Metal Stent
  IMPERIAL RCT
(n = 309)
MAJESTIC
(n = 57)
SuperNOVA
(n = 299)
TLR 4.5% (13/292) at 1 year 3.6% (2/56) at 1 year
7.1% (4/56) at 2 years
14.5% (8/55) at 3 years
13.5% (38/281) at 1 year
21.7% (60/276) at 2 years
24.5% (65/265) at 3 years
  • All events were CEC adjudicated.
  • The SUPERNOVA Trial studied the Innova Bare Metal Stent. Innova is the bare metal platform for the Eluvia Drug-Eluting Stent.
  • Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
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