SELUTION FIM Study
In October 2016 MedAlliance launched the SELUTION FIM prospective controlled multi-centre study across 4 German clinical investigation sites, patient enrolment was completed in May 2017.
To assess the safety and efficacy of the SELUTION SLR™ DEB in treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of SFA and/or PA, assessed at multiple time points clinical, angiographic and/or ultrasound assessment
- Prospective, controlled, multi-center, open, single-arm clinical investigation
- 50 patients
- Angiographic Late Lumen Loss (LLL) by QVA – 6 months
- Major adverse Events (Death, Thrombosis, Amputation, CD-TLR) – 6 months
- Primary Patency – Freedom from CD-TLR and absence of Restenosis by DUS – 6, 12 and 24 months
- Angiographic Binary Restenosis (ABR) by QVA – 6 months
- Composite of Freedom from Amputation and Freedom from CD-TVR – 12 and 24 months
- Change of ABI, WIQ and Qol – 6, 12 and 24 months
The primary endpoint was achieved with median Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at six months post-index procedure, being 0.19mm (-1.16; 3.07). The rate of Target Lesion Revascularization (TLR) was 2.3% – one of the lowest that has ever been reported in a drug-coated balloon FIM study at six months.
There were no incidences of either death or the need for minor and/or major amputations. A sub-group analysis, looking at patients with long lesions (mean 112.05 ± 25.31 mm), demonstrated similar safety and efficacy data compared to the overall cohort. LLL was 0.23 mm in this subgroup and TLR rate was 0%.