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IMPERIAL randomised controlled trial results

IMPERIAL randomised controlled trial results

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-Year.7,8,9,10

The IMPERIAL RCT demonstrated that Eluvia DES is clinically effective and safe in treating patients with symptomatic SFA disease both in the short-term during the height of restenosis risk, and long-term out to five years.

IMPERIAL RCT 1-year primary patency results

Chart with Primary Patency Results* 92.1% Eluvia DES 81.8% Zilver PTX

IMPERIAL RCT 2-year primary patency results¹²

Imperial RCT 2 year results, showing Eluvia with highest primary patency.

2-year clinically-driven target lesion revascularisation (TLR)

Eluvia DES had statistically significant fewer CD-TLRs compared to Zilver PTX at 2-Years.16

Bar chart showing clinically driven TLR 37% reduction for Eluvia DES

IMPERIAL randomised controlled trial details

2-Year Primary Endpoints Eluvia DES
Zilver PTX 
Primary Patency 83.0% 77.1% 0.1008
Major Adverse Events 14.2% 20.1% 0.1236
Mortality Rates Eluvia DES Zilver PTX p-value
1-Year All-Cause Mortality 2.1% 4.0% 0.23
2-Year All-Cause Mortality 7.1%
Baseline Characteristics

Eluvia DES

Zilver PTX 

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%
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%

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7. Gray W. 2-year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX; LINC 2020, Leipzig Jan 28,2020.

8. Kaplan-Meier Primary Patency Estimate through 1-Year (including follow-up window) was statistically significant with a p-value of 0.0094.

9. 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.

10. Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 1-Year follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.

11. Log-rank p-value compares the entire K-M curves from time zero to full 1-Year follow-up window.

12. Intention to treat. Adapted from Iida, O VIVA 2019 Presentation. Kaplan-Meier estimate utilizing time-to-event of clinically-driven TLR up to 730 days and Duplex Ultrasound data at 2-Years. 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.

13. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83.0% vs. 77.1% for Zilver PTX at 2-Years, p=0.1008.

14. Vermassen, F. VIVA Late-Breaking Clinical Trials June 2020.

15. Iida, O. IMPERIAL Head to Head Randomized Study of Eluvia and Zilver PTX. Two-Year Outcomes & Japanese Patients. JET 2020.

16. Intention to treat. Iida O, VIVA 2019. RCT, randomized controlled trial; TLR, target lesion revascularization.

17. Gray, W. 2 year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX. LINC 2020.

The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.