Elegance clinical study.It was reported that the subject passed away.On (b)(6) 2023, the subject underwent treatment with eluvia drug eluting stents as part of the elegance clinical trial.The target lesion was located in the 100% stenosed left proximal superficial femoral artery (sfa) extending up to the left mid-sfa; with a 5 mm proximal reference vessel diameter, and a 5 mm distal reference vessel diameter, with a 240 mm lesion length.The lesion was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to the treatment of the target lesion with the study devices, pre-dilation was performed using 6 mm x 150 mm and 5 mm x 120 mm percutaneous transluminal angioplasty balloon.Treatment of the target lesion was then performed by placement of two 6 mm x 120 mm drug eluting stents, and one 6 mm x 40 mm eluvia drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged from the hospital on dual anti-platelet therapy.On approximately (b)(6) 2023, the subject passed away.
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