Elegance clinical trial.It was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion 1 was in the left anterior tibial artery with 2 mm proximal reference vessel diameter and 1.4 mm distal reference vessel diameter with lesion length 150 mm with 100% stenosis.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 2 mm x 200 mm armada pta balloon.Treatment of target lesion was performed by dilation using 2.5 mm x 150 mm ranger drug coated balloon, study device.Post treatment, the final residual stenosis was noted to be 10%.On (b)(6) 2023, subject was noted with symptoms related to restenosis in the left anterior tibial artery.On (b)(6) 2024, the subject experienced tightness in the left calf after walking for a long distance along with numbness.On (b)(6) 2024, subject was admitted to the hospital for further evaluation and treatment.On the same day, subject underwent angiography which revealed: aorta and iliac vessels revealed no significant disease.Right leg: normal flow was noted in the common femoral artery, profunda femoris artery, superficial femoral artery, popliteal artery.The flow was predominant via the anterior tibial artery with stenotic disease in the mid anterior tibial artery.Left leg (target limb): normal flow was noted in the common femoral artery, profunda femoris artery, superficial femoral artery, and popliteal artery.High grade stenosis was noted in the proximal anterior tibial artery as well as occlusion in its mid-section.The tibial vessels were noted to be occluded with flow into a very small dorsalis pedis artery via the collateral vessels.On (b)(6) 2024, 182 days post index procedure, restenosis noted in left anterior tibial artery was treated by atherectomy using a non-boston scientific (bsc) atherectomy device followed by drug coated balloon angioplasty using 3 mm x 150 mm, and 2.5 mm x 120 mm ranger drug coated balloons (tlr/002).Post procedure, improved flow was noted through the anterior tibial artery down to the foot.On the same day, the event was considered resolved with sequelae.On 29-feb-2024, the subject was discharged from the hospital.
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