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Global Benchmark · World's Only RCT · CX 2026
SIRONA Trial
Global Benchmark

36-month clinical outcomes from the world's only head-to-head randomised controlled trial comparing Sirolimus vs Paclitaxel-coated balloons, demonstrating MagicTouch PTA superiority over Paclitaxel-coated balloons in SFA treatment for cd-TLR. Presented at CX 2026.

Prof. Ulf Teichgräber
CX 2026
MagicTouch PTA · SCB
View Presentation SIRONA Trial · 36-Month Data · CX 2026
Preliminary before CEC adjudication
88.2%
SCB Freedom from cd-TLR at 36 months
HR 0.60
Hazard Ratio · CI 0.36–0.97
p = 0.03
Log-rank Statistical Significance
482

Patients Enrolled

238 in the Sirolimus (SCB) group and 244 in the Paclitaxel (PCB) group across multiple centres.

36 months

Follow-up Period

Long-term 36-month clinical outcomes confirming sustained and superior treatment efficacy.

SCB+

Superior Outcomes

World's only RCT with head-to-head comparison: Sirolimus vs Paclitaxel in SFA treatment.

SIRONA Trial – 36 Months Clinical Outcomes

Preliminary data before CEC adjudication. All three endpoints presented at Charing Cross Symposium 2026.

Freedom from cd-TLR
MagicTouch PTA (SCB) 88.2%
Paclitaxel Coated Balloon (PCB) 80.2%
Log-rank p = 0.03  ·  HR: 0.60 (CI 0.36–0.97)
✓ SCB shows superior and sustained outcomes at 3 years
Freedom from
Major Amputation
MagicTouch PTA (SCB) 99.6%
Paclitaxel Coated Balloon (PCB) 99.6%
Log-rank p = 0.61  ·  HR: 0.54 (CI 0.04–5.96)
No statistically significant difference
All-Cause
Mortality
MagicTouch PTA (SCB) 92.6%
Paclitaxel Coated Balloon (PCB) 92.6%
Log-rank p = 0.67  ·  HR: 1.12 (CI 0.59–2.27)
No difference between groups

Key Findings

Superiority of SCB vs PCB
At 3 years, MagicTouch PTA was superior to PCB for:
Statistically significant improvement demonstrated in:
  • Freedom from clinically driven TLR
No Significant Difference
At 3 years, MagicTouch PTA did not differ from PCB in:
No statistically significant difference observed in:
  • Major amputation
  • All-cause mortality
  • Pain-free walking distance
Principal Investigator: Prof. Ulf Teichgräber
Freedom from cd-TLR
SCB Superiority Confirmed at 3 Years
The Sirolimus-coated balloon achieved 88.2% freedom from cd-TLR at 36 months versus 80.2% for PCB — a statistically significant difference (Log-rank p = 0.03, HR: 0.60, CI 0.36–0.97). Preliminary before CEC adjudication.
View Presentation
Full 36-month clinical data · CX 2026 · Prof. Ulf Teichgräber

Academic & Informational Disclosure: This page features content derived from a scientific presentation delivered at the Charing Cross International Symposium 2026 (CX 2026) on April 21, 2026. It is shared by Concept Medical for academic and informational purposes only. The material is presented in its original form and reflects the data and interpretations available at the time of presentation. It may not include subsequent updates or peer-reviewed validation. For clinical decision-making, please refer to published scientific literature or consult the respective authors.

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