- Highest-two year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomisation for Zilver PTX RCT.
Discover our detailed IMPERIAL Trial Results
1-Year Trial Results
(12-month results from IMPERIAL, the world's first head-to-head DES SFA Trial1 - Presented at LINC 2020)
*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 randomised controlled multi-center trial with 2:1 randomisation 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).


2-Year Trial Results

"We were hoping that we would see a device that would allow us to tell our patients that we would have mid-80% patency at 24 month follow-up."
Hear Dr. Robert Lookstein's Commentary on Eluvia's 2-Year Data
Robert Lookstein, MD
Mount Sinai Medical Center
New York, NY
2-Year Durable and Consistent Results in Complex Lesions


* Highest-two year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomisation for Zilver PTX RCT. Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
** Intention to treat. Kaplan-Meier estimate utilizing time-to-event of clinically-driven TLR up to 730 days and Duplex Ultrasound data at 24 months. 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.
- IMPERIAL Trial: A global randomised controlled multi-center trial with 2:1 randomisation 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).
- In IMPERIAL RCT, Eluvia K-M Primary Patency was 83% vs. 77.1% for Zilver PTX at 24 months, p=0.1008.
- Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.
- 70% of IMPERIAL Long Lesion Sub-study lesions were Severe/Moderate Calcium.
2-Year Results

In IMPERIAL RCT, Eluvia demonstrated a statistically significant reduction in TLR vs. ZilverTM PTXTM at 24 months

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)

2-Year All-Cause Mortality Rate for Eluvia

All cause mortality for Eluvia was within range expected for symptomatic peripheral arterial disease*
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
- 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


Interested to know more about our randomised clinical trials?
Read about EMINENT, the world largest Randomised Clinical Trial (RCT) comparing Eluvia DES to BMS in the SFA/PPA >

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