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It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016, and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 90% stenosis.The target lesion was 34 mm long with a proximal reference vessel diameter of 5 mm and a distal vessel diameter of 5.4 mm.It was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a 6 mm x 60 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin.On (b)(6) 2020, the subject was noted to have intra stent stenosis in the right sfa and stenosis in the left sfa.On (b)(6) 2020, intra stent stenosis noted in the right sfa was treated by performing percutaneous transluminal angioplasty using a drug-coated balloon.Post balloon angioplasty, the residual stenosis was noted to be 10%.Additionally, the stenosis noted in the left sfa was treated by angioplasty.On (b)(6) 2020, both events were considered resolved.
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It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016, and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 90% stenosis.The target lesion was 34 mm long with a proximal reference vessel diameter of 5 mm and a distal vessel diameter of 5.4 mm.It was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of a 6 mm x 60 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin.On (b)(6) 2020, the subject was noted to have intra stent stenosis in the right sfa and stenosis in the left sfa.On (b)(6) 2020, intra stent stenosis noted in the right sfa was treated by performing percutaneous transluminal angioplasty using a drug-coated balloon.Post balloon angioplasty, the residual stenosis was noted to be 10%.Additionally, the stenosis noted in the left sfa was treated by angioplasty.On (b)(6) 2020, both events were considered resolved.It was further reported that on (b)(6) 2020, the subject presented to hospital for post-angioplasty follow-up and subsequently, a doppler of the lower limb arteries was performed, which revealed the following.In the right limb, there was significant intra-stent stenosis in the superficial and deep femoral arteries.Flows were bi to triphasic.The ankle brachial index was estimated to be 0.7.In the left limb, there was significant stenosis noted in the left deep, common, and superficial femoral arteries.Flows were bi to triphasic in the iliac-femoral portion and monophasic in the distal popliteal portion.The ankle brachial index was estimated to be 0.6.On (b)(6) 2020, the subject visited the hospital for further evaluation and possible treatment.Subsequently, arteriography was performed to the subject which revealed the following.In the right lower limb, intrastent stenosis was noted in the distal third of the sfa with the proximal stenosis noted to be 70% at the entry of the stent and second stenosis noted to be 60%.The artery upstream from the stent noted mildly atheromatous with some zones of narrowing.Occlusion noted in the posterior tibial artery.In the left lower limb, atheromatosis with stenosis of about 50% noted in the common femoral artery.Stenosis of more than 50 % noted in the middle and distal third of the superficial artery with atheromatous infiltration.Calcified atheromatous plaque noted in the proximal portion of the popliteal artery.Occlusion noted in the posterior tibial artery.On (b)(6) 2020, intra stent stenosis noted in the right sfa was treated by performing percutaneous transluminal angioplasty using a 6mm drug coated balloon.The vessel proximal to the stent was treated by drug eluting balloon angioplasty of 5 mm.Following post dilation, the residual stenosis was noted to be 10%.Stenosis noted in the left sfa was treated by percutaneous transluminal angioplasty using drug coated balloon of 5 x 80 mm followed by dilation with 6 x 20 mm balloon.Additionally, significant stenosis with calcified plaques in the common femoral artery was treated by balloon angioplasty using 6 mm drug eluting balloon.Following post dilation, angiography was performed which revealed satisfactory result with residual stenosis of less than 30%.
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