Elegance clinical study it was reported that a grade f dissection was noted, requiring additional devices.On (b)(6) 2023, the subject underwent treatment with eluvia drug eluting stents as part of the elegance clinical trial.The target lesion was 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.Multiple attempts were made to cross the occluded segment of left sfa with a v-18 guidewire combined with an unknown catheter.Therefore, retrograde passage was made through the left proximal popliteal artery to establish guidewire pathway.Prior to the treatment of the target lesion with the study devices, pre-dilation of the occluded left sfa was performed using 6 mm x 150 mm and 5 mm x 120 mm percutaneous transluminal angioplasty mustang balloons.Angiography was performed which revealed a grade f flow limiting dissection; therefore, was treated with the placement of eluvia stents.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.
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