Clinical Trials

MedAlliance is committed to developing clinical data to advance the treatment of cardiovascular and peripheral disease.

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.

OBJECTIVES

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

DESIGN

  • Prospective, controlled, multi-center, open, single-arm clinical investigation
  • 50 patients

PRIMARY ENDPOINTS

  • Angiographic Late Lumen Loss (LLL) by QVA6 months

SECONDARY ENDPOINTS

  • 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-TVR12 and 24 months
  • Change of ABI, WIQ and Qol6, 12 and 24 months

RESULTS

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%.