The SELUTION SFA trial met its primary endpoint and demonstrated an late lumen loss of 0.19mm. Furthermore, excellent freedom from clinically driven TLR was achieved through 24 months in 87.5%, with no primary TLR event observed after month 11. Thomas Zeller (Bad Krozingen, Germany) presented these results at the 2019 Vascular Interventional Advances conference (VIVA) in Las Vegas, USA (4–7 November).
SELUTION SFA is a prospective, controlled, multicentre, open-label, single-arm clinical trial treating superficial femoral artery (SFA) lesions (lesion length, 51.3±40.3 mm; 34% moderate to severe calcification). The trial enrolled 50 patients in four German centres between November 2016 and May 2017. Patients enrolled were symptomatic with de novo or restenotic lesions with ≥70% diameter stenosis or occlusion.
Clinical improvements were seen in Rutherford classification, ABI, and walking impairment at six months and were further improved to 12 months and maintained to 24 months. This initial first-in-human trial demonstrates that SELUTION SLR is a viable option to treat lesions in the SFA. It is the first demonstration of a sirolimus safety and efficacy in peripheral intervention.
The SELUTION SLR (MedAlliance) is based on microreservoir balloon coating technology, which provides controlled and sustained sirolimus release with a therapeutic effect for over 60 days. The cell adherent technology is a proprietary amphiphatic lipid technology that binds microreservoirs to the balloon surface, and it contains and protects microreservoirs during insertion and inflation. Also, it facilitates higher drug transfer efficiency, allowing for low drug dose (1 µg/mm2) on the balloon surface, and maximises the drug bioavailability.