Aortic & peripheral vascular diseaseCohort study
3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon
- Prospective single-arm study
- multicentre
- independent imaging core laboratory and clinical events committee adjudication
Authors' conclusion
Three-year results from the SELUTION SFA JAPAN study demonstrated durability of the SELUTION DEB and confirmed it is a safe and effective treatment option for FP disease in symptomatic patients.
Study context
- Population
- Japanese patients with symptomatic femoropopliteal diseasemedian follow-up 1,089 days
- Participants
- 134 patients
- Outcome
- Primary patency, target lesion revascularization and major adverse events
- Follow-up
- 36 months
Main finding
As reported in the abstract
Primary patency and freedom from clinically driven TLR
36-month primary patency rate
81.5% (95% CI: 73.7%-87.2%)
Freedom from clinically driven target lesion revascularization (TLR)
93.8% (95% CI: 88.0%-96.9%)
Observational data: associations, not effects.
Further findings
Ankle-brachial index and Rutherford class · through 36 months
- Marked and sustained improvements
Safety
Major adverse events · 36 months
- Major adverse event rate
- 14.2%
- Clinically driven TLRs
- 8
- All-cause deaths
- 11
- Device- or procedure-related
- 0
- none were related to the device or procedure
Original publication
3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon. JACC Cardiovasc Interv. Published 10 November 2025. doi:10.1016/j.jcin.2025.08.041
Summarised from the published abstract; every number is checked against it