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

EMINENT Trial
1-Year Results

Discover our detailed EMINENT Trial Results

 

1-Year Trial Results

Eluvia DES demonstrated a statistically significant superior primary patency and sustained clinical improvement compared to bare metal stent (BMS) at 1 year.

12-month results from EMINENT, the world largest Randomised Clinical Trial (RCT) comparing Eluvia DES to BMS in the SFA/PPA.

 

EMINENT RCT 1-Year Primary Patency Results1

Eluvia demonstrated superiority over BMS1 with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.

EMINENT RCT 1-Year Primary Patency Results

EMINENT RCT 1-Year Primary Patency Results

Eluvia demonstrated sustained clinical improvement

Eluvia demonstrated sustained clinical improvement

*Kaplan-Meijer Estimate: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 1-Year in the absence of clinically-driven TLR or bypass of the target lesion.
**Log rand p-value compares the entire K-M curves from time point zero to day 390 (full 1-Year follow-up window)
 

EMINENT 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.

EMINENT Trial Design

RCT (Eluvia DES vs Bare Metal Stent)
  • 2:1 randomised
  • Single-blind
  • Superiority trial
  • Patients: N=775 | Eluvia N=508 vs BMS N=267
  • Primary Endpoint: 12-month primary patency
  • Investigational centers: 58 study centers in 10 European countries

Baseline Characteristics

EMINENT Randomised Controlled Trial Details
EMINENT Trial Eluvia Baseline Characteristics
EMINENT Trial Eluvia 1 Year Safety
*Kaplan-Meier Estimate: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 1-Year 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 point zero to day 390 (full 1-year follow-up window)
***In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.
1. EMINENT Clinical Trial 1-Year results presented by Professor Yann Goueffic, MD. VIVA 2021
2. Gray WA, et al; A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. 1-Year Results. The Lancet. 2018 Oct 27;392(10157):1541-1551. doi: 10.1016/S0140-6736(18)32262-1. Epub 2018 Sep 24. PMID: 30262332. .



Interested to know more about our randomised clinical trials?
Read about IMPERIAL, the world’s first head-to-head Randomised Controlled Trial (RCT) comparing Eluvia™ Drug-Eluting Vascular Stent System to Zilver PTX for SFA/PPA >

 

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