Elegance study it was reported that a dissection of grade d occurred.The subject underwent treatment with the ranger drug-coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 7 mm proximal reference vessel diameter and 7 mm distal reference vessel diameter with lesion length 250 mm with 90% stenosis and was classified as tasc ii b lesion.Prior to the treatment of target lesion with study device, lithotripsy was performed by using 6 mm x 60 mm non-boston scientific (bsc) lithotripsy device.Treatment of the target lesion was performed by dilation using study devices, 6 mm x 200 mm and 6 mm x 100 mm ranger drug-coated balloons followed by the placement of two 7 mm x 120 mm eluvia drug-eluting stents.Following treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade d was noted in the target lesion due to 6 mm x 200 mm ranger drug-coated balloon.In response to the complication, a bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the complication of dissection was resolved.On the same day, the subject was discharged from hospital on aspirin and clopidogrel.
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