Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right anterior tibial artery with 3.5 mm proximal reference vessel diameter and 2 mm distal reference vessel diameter with lesion length 320 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 2 mm x 150 mm coyote pta balloon.Treatment of target lesion was performed by dilation using study devices, 2.5 mm x 120 mm, 3 mm x 120 mm and 3.5 mm x 150 mm ranger drug coated balloons.Following treatment, the final residual stenosis was noted to be 15%.On the (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, subject was noted with symptoms related to restenosis of right anterior tibial artery and was hospitalized for further evaluation and treatment.On (b)(6) 2023, 261 days post index procedure, 70% stenosis noted in the right anterior tibial artery was treated with balloon dilation using coyote pta balloon.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved and on (b)(6) 2023, the subject was discharged from the hospital.
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