Elegance clinical study it was reported that restenosis occurred, requiring revascularization.On (b)(6) 2022, the subject underwent treatment with this 6x80, 130 cm eluvia drug-eluting vascular stent system and a ranger drug coated balloon as part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to right distal sfa with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 200 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed, and pre-dilation was performed by using a 3 mm x 25 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, a 4 mm x 220 mm pta balloon, a 5 mm x 200 mm pta balloon, and a 5 mm x 120 mm pta balloon.Treatment of the target lesion was then performed by dilation using the study devices, a 6 mm x 200 mm ranger drug coated balloon, and this 6 mm x 80 mm eluvia drug eluting stent.Post-dilation was performed using a 5 mm x 60 mm pta balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On 18-may-2023, the subject was referred for bilateral lower extremity arterial duplex due to claudication and history of right sfa stent left iliac stent.Bilateral lower extremity arterial duplex was performed which revealed on the right side: more than 75% stenosis the proximal sfa, and calcification in external iliac, common femoral, mid-sfa and distal sfa, deep femoral, popliteal, posterior tibial, peroneal, anterior tibial and dorsalis pedis which was consistent with less than 50% stenosis.On (b)(6) 2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain for the past one year.On the same day, abdominal aortogram revealed mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, the right ileo-femoral artery system was patent with no significant disease, patent right internal iliac artery, left common iliac artery stent was patent with no angiographic evidence of restenosis, patent left external iliac artery with no significant disease, occluded left internal iliac artery.Selective angiography of the right lower extremity revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, occluded sfa at distal segment, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.On the same day, occlusion noted in the right proximal sfa, right mid-sfa, and right distal sfa.These were treated using atherectomy and thrombectomy devices followed by dilation using balloon and drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On the same day, the event was considered to be resolved.
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