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ELUVIA VS. ZILVER PTX

IMPERIAL
Randomised Controlled Trial results  

IMPERIAL Clinical Trial Results

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.

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IMPERIAL RCT 1-year primary patency results

Eluvia Drug-eluting stent demonstrated superiority over Zilver PTX with a statistically significant primary patency through 1-Year.1

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

IMPERIAL RCT 2-year primary patency results2-6

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

 Freedom from CDTLR rates

Eluvia DES showed lower revascularization rates than Zilver PTX through 5 years with statistical significance at 2-Years.

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

IMPERIAL randomised controlled trial details

2-Year Primary EndpointsEluvia DES
(n=309)		Zilver PTX 
(n=156)		p-value
Primary Patency83.0%77.1%0.1008
Major Adverse Events14.2%20.1%0.1236
Mortality RatesEluvia DESZilver PTXp-value
1-Year All-Cause Mortality2.1%4.0%0.23
2-Year All-Cause Mortality7.1%
(21/295)		8.3%
(12/145)		0.6649
Baseline Characteristics

Eluvia DES
(n=309)

Zilver PTX 
(n=156)

Age (Years)68.5 ± 9.567.8 ± 9.4
Male Gender66.0%66.7%
Diabetes Mellitus41.7%43.6%
History of Smoking86.1%84.0%
Target Lesion Length (mm)86.5 ± 36.981.8 ± 37.3
Severely Calcified40.1%32.3%
Total Occlusions31.2%30.3%
Extending into Distal SFA66.3%65.4%
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1. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization 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). Gray WA, Lancet. 2018 Sep 24. pii: S0140-6736(18)32262-1.

2. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83% vs. 77.1% for Zilver PTX at 24 months, p=0.1008. 

3. Golzaar, J. et al, Journal of Endovascular Therapy, Jan 2020. https://doi.org/10.1177/1526602820901723.

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

5. In IMPERIAL Diabetic Subgroup, Eluvia K-M Primary Patency was 95.2% vs. 81.5% for Zilver PTX at 12 months. Diabetic = Medically Treated Diabetes

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

7. Gray W. 5-year Results from the IMPERIAL Randomized Study of Eluvia and Zilver PTX Drug-eluting Stents and Long Lesion Substudy for Femoropopliteal Artery Disease; CRT 2023, Washington DC Feb 27, 2023.

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

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