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.
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](/en-EU/medical-specialties/vascular-surgery/drug-eluting-stent-drug-coated-balloon/clinical-studies/eluvia-clinical-evidence/imperial-clinical-trial-results/_jcr_content/root/container/container_947831390/container_1510545751/image_copy.coreimg.png/1689096577431/eluvia-primary-patency-rates-zilver-d.png)
IMPERIAL RCT 2-year primary patency results2-6
![Imperial RCT 2 year results, showing Eluvia with highest primary patency.](/en-EU/medical-specialties/vascular-surgery/drug-eluting-stent-drug-coated-balloon/clinical-studies/eluvia-clinical-evidence/imperial-clinical-trial-results/_jcr_content/root/container/container_947831390/container_1510545751/image_copy_copy.coreimg.png/1689096636003/imperial-rct-2-year-primary-patency-rate-results-data-d.png)
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](/en-EU/medical-specialties/vascular-surgery/drug-eluting-stent-drug-coated-balloon/clinical-studies/eluvia-clinical-evidence/imperial-clinical-trial-results/_jcr_content/root/container/container_947831390/container_1510545751/image_copy_copy_copy.coreimg.png/1706002627043/imperial-new-graphic.png)
IMPERIAL randomised controlled trial details
- 2-year primary endpoints
- Mortality rates
- Baseline characteristics
2-Year Primary Endpoints | Eluvia DES (n=309) | Zilver PTX (n=156) | p-value |
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% (21/295) | 8.3% (12/145) | 0.6649 |
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% |