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Clinical Results
EMINENT Randomized Clinical Trial Results1
EMINENT is the largest RANDOMIZED CONTROLLED TRIAL (2:1) comparing Eluvia™ Drug-Eluting Vascular Stent System to self-expanding bare metal stents (BMS) for SFA/PPA EU multi-center; superiority trial; core lab adjudicated.
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.
![1-Year Primary kaplen meijer Patency estimate](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_305821580.img.eluvia-primary-patency-rates-d.png)
**Log rand p-value compares the entire K-M curves from time point zero to day 390 (full 1-Year follow-up window)
ELUVIA DEMONSTRATED SUSTAINED CLINICAL IMPROVEMENT1
Eluvia demonstrated a statistically significant greater rate of sustained clinical improvement without reintervention over BMS through 1-Year.
![EMINENT Trial Eluvia 1 Year Primary Sustained](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_588631485.img.eminent-eluvia-1-year-primary-sustained-d.png)
EMINENT Randomized Controlled Trial Details
![EMINENT Trial Eluvia Baseline Characteristics](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_1313332345.img.eminent-eluvia-keybaseline_characteristics-d.png)
![EMINENT Trial Eluvia 1 Year Safety](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_1689992602.img.eminent-eluvia-1-year-safety-results-d.png)
**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. .
IMPERIAL Randomized Controlled Trial Results1,2
Eluvia DES demonstrated statistically significant difference in primary patency versus Zilver PTX and achieved the highest primary patency reported in any SFA DE Pivotal Trial at 1-Year3.
IMPERIAL RCT 1-Year Primary Patency Results*
Eluvia demonstrated superiority over BMS1 with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.
![Chart with Primary Patency Results* 92.1% Eluvia DES 81.8% Zilver PTX](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image.img.eluvia-primary-patency-rates2.jpg)
** Log-rank p-value compares the entire K-M curves from time zero to full 1-Year follow-up window.
IMPERIAL RCT 2-Year Primary Patency Results*
![Imperial RCT 2 year results, showing Eluvia with highest primary patency.](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_copy_copy_1612857280.img.imperial-rct-2-year-primary-patency-rate-results-data-d.png)
*** Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.
2-Year Clinically-Driven TLR4
Eluvia DES had statistically significant fewer CD-TLR’s compared to Zilver PTX at 2-Years.
![Bar chart showing clinically driven TLR 37% reduction for Eluvia DES](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_copy_copy.img.eluvia-imperial-rct-2-year-clinically-driven-tlr-data-d.png)
IMPERIAL Randomized Controlled Trial Details
![Chart showing Eluvia 1-Year primary endpoint patency Eluvia DES 86.8%](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_copy_copy_copy_1547202158.img.eluvia-1-year-primary-endpoints-data-d.png)
![Chart with Eluvia DES 1 year (2.1%) and 2 Year (7.1%) mortality rates](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_copy_copy_copy.img.eluvia-mortality-rates-data-d.png)
![Chart of Eluvia DES baseline characteristics](https://www.bostonscientific.com/en-EU/medical-specialties/vascular-surgery/drug-eluting-therapies1/eluvia/eluvia-clinical-trials/_jcr_content/fullBleedTileContent-par/fullbleedtile_185373/maincontentFullBleed-par/image_1176856292.img.eluvia-des-baseline-characteristics-data-d.png)
2. Kaplan-Meier Primary Patency Estimate through 1-Year (including follow-up window) was statistically significant with a p-value of 0.0094.
3. Based on 1-Year Kaplan-Meier estimates reported for IMPERIAL, RANGER II SFA, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver PTX RCT.
4. Long Lesion TLR data is as-treated as presented at FDA panel 2019. All other data sets are intention to treat, adapted from Gary, W. LINC 2020 presentation.
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