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Imperial clinical trial.It was reported that occlusion and ischemia occurred.The patient underwent treatment with the study stent on (b)(6) 2016 as part of the imperial clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) and extended to proximal popliteal artery.The target lesion was 100% stenosed and was 130mm long with a proximal reference vessel diameter of 5mm and distal vessel diameter of 5mm.The lesion was classified as tasc ii c lesion.Pre-dilatation was performed and one 6mm x 150mm study stent was implanted.Post-dilatation was performed, resulting in 20% residual stenosis.On (b)(6) 2019, patient was diagnosed with acute limb ischemia of the extremity of the right leg and hospitalized for further evaluation the same day.A peripheral angiogram was performed.On (b)(6) 2019 100% of stenosis noted in right limb was treated with percutaneous transluminal angioplasty with 50% residual stenosis.On (b)(6) 2019, the event was considered resolved with residual effects and the subject was discharged on the same day.On (b)(6) 2019 days post procedure, the subject was diagnosed with right sfa re-occlusion.In response to the event, angiogram of right lower angiogram was performed.It was further reported that on (b)(6) 2019, patient was diagnosed with the acute limb ischemia with abrupt pain and numbness in the right leg for a week which worsened with walking.On (b)(6) 2019, an abdominal aortography and angiography of the bilateral lower extremity was performed which revealed the right external and internal iliac artery, and common femoral artery were moderately calcified with disease; the proximal, mid, distal and popliteal part of superficial femoral artery were occluded.A percutaneous transluminal angioplasty (pta) was performed in the occluded right sfa, including dilation via ballooning.The ballooning was performed with a 3 x 220 mm balloon at 8 atm distally and proximally, 4 x 220 mm balloon at 12 atm in the mid and proximal vessel and 5 x 220 mm balloon at 10-12 atm within the stents and proximally.On (b)(6) 2019, patient visited hospital for a scheduled outpatient lower extremity angiogram.Patient had numbness in right foot along with shooting pain in toes.The angiogram revealed occlusions in the right proximal sfa, right popliteal artery, and right posterior tibial artery.On the same day, rotational atherectomy was performed in the entire right sfa and popliteal artery.Post intervention there were diffused plaque and thrombus present in the stented segment so to additional stents were placed, a 6x200 mm and 7.0x200 mm, overlapping each other.The stents were post dilated with 6.0 x 220 mm balloon and popliteal artery was additionally treated with ballooning with 6.2 x 220 mm balloon.The posterior tibial artery and tibioperoneal trunk were treated with serial inflations of 3.0 x 80 mm balloon.Post intervention, superficial femoral artery at the site of stent deployment was patent, 10-20% residual stenosis in the posterior tibial artery and 20% residual stenosis in the popliteal artery.It was further reported that on (b)(6) 2019, the subject had multiple comorbidities with cad (elevated cardiac enzymes), ckd (stage iv; elevated creatinine), chronic combined chf, elevated hld and low platelet count.On (b)(6) 2019, mild disease in left common femoral; patent profunda, mid 60% stenosis of sfa; 90% mid popliteal stenosis and occluded anterior tibial was noted in the left limb.On the same day, 1079 days post procedure, the complete occlusion noted in right sfa and right popliteal was treated by performing percutaneous transluminal angioplasty.Post ballooning, the residual stenosis was 50% and the blood flow was found to be markedly increased.Additionally, total occlusion noted in right tibial-peroneal trunk and posterior tibial artery was treated by performing pta.On (b)(6) 2019, follow-up core-lab angiography finding dated (b)(6) 2019, noted thrombus of grade 0 and absence of aneurysm and presence of isr pattern 4.No stent deformation or stent fracture was noted.Baseline angio-core lab dated (b)(6) 2016, revealed radial stent deformation of study stent.On october 30, 2018, 24 month scheduled follow-up, x-ray core lab revealed, grade i stent fracture identified as single tine fracture at distal part of stent.No further information is available or expected from the site.On (b)(6) 2019, the subject visited hospital with the complaints of constant right foot numbness and shooting pain in toes.Subsequently, right limb duplex ultrasound was performed which revealed occluded right sfa and popliteal stents; occluded right ata and peroneal artery.Right abi was 0.46.The subject was recommended for repeat peripheral angiogram and possible treatment.The subject was noted with low platelet counts; hence hematology was consulted.Per hematology, the subject has history of thrombocytopenia since 2013 and the subject refused bone marrow biopsy.Subsequently, the subject was advised for platelets monitoring and was referred for nephrology.Later on, the same day, the right lower extremity angiogram was performed which revealed: 50 % disease in common femoral artery, diseased profunda femoris, 80 to 90% stenosis in the proximal sfa.Right proximal sfa: occluded, right popliteal artery: occluded and right posterior tibial artery: occluded, completely occluded tented segment in sfa; 80-90% distal popliteal artery stenosis and 99% stenosis in proximal to mid segment.Repeat angiography revealed diffused plaque and thrombus present in the stented segment.Hence, 6.0 x 200 mm and 7.0 x 200 mm non study stents were placed in the affected area overlapping each other.Following post dilatation, popliteal artery was additionally treated with ballooning with 6.2 x 220 mm balloon.Additionally, the posterior tibial artery and tibial-peroneal trunk were treated with serial inflations of 3.0 x 80 mm balloon.Post intervention, superficial femoral artery at the site of stent deployment was patent, 10-20 % residual stenosis in the posterior tibial artery and 20% residual stenosis in the popliteal artery.Baseline angio-core lab dated (b)(6) 2016, revealed radial stent deformation of study stent.On (b)(6) 2018, 24 month scheduled follow-up, x-ray core lab revealed, grade i stent fracture identified as single tine fracture at distal part of stent.Follow-up core-lab angiography finding dated (b)(6) 2019, noted thrombus of grade 0 and absence of aneurysm and presence of isr pattern 4.No stent deformation or stent fracture was noted.No further information is available or expected from the site.
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Imperial clinical trial.It was reported that occlusion and ischemia occurred.The patient underwent treatment with the study stent on (b)(6) 2016 as part of the imperial clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) and extended to proximal popliteal artery.The target lesion was 100% stenosed and was 130mm long with a proximal reference vessel diameter of 5mm and distal vessel diameter of 5mm.The lesion was classified as tasc ii c lesion.Pre-dilatation was performed and one 6mm x 150mm study stent was implanted.Post-dilatation was performed, resulting in 20% residual stenosis.On (b)(6) 2019, patient was diagnosed with acute limb ischemia of the extremity of the right leg and hospitalized for further evaluation the same day.A peripheral angiogram was performed.On (b)(6) 2019 100% of stenosis noted in right limb was treated with percutaneous transluminal angioplasty with 50% residual stenosis.On (b)(6) 2019, the event was considered resolved with residual effects and the subject was discharged on the same day.On (b)(6) 2019 days post procedure, the subject was diagnosed with right sfa re-occlusion.In response to the event, angiogram of right lower angiogram was performed.It was further reported that on (b)(6) 2019, patient was diagnosed with the acute limb ischemia with abrupt pain and numbness in the right leg for a week which worsened with walking.On (b)(6) 2019, an abdominal aortography and angiography of the bilateral lower extremity was performed which revealed the right external and internal iliac artery, and common femoral artery were moderately calcified with disease; the proximal, mid, distal and popliteal part of superficial femoral artery were occluded.A percutaneous transluminal angioplasty (pta) was performed in the occluded right sfa, including dilation via ballooning.The ballooning was performed with a 3 x 220 mm balloon at 8 atm distally and proximally, 4 x 220 mm balloon at 12 atm in the mid and proximal vessel and 5 x 220 mm balloon at 10-12 atm within the stents and proximally.On (b)(6) 2019, patient visited hospital for a scheduled outpatient lower extremity angiogram.Patient had numbness in right foot along with shooting pain in toes.The angiogram revealed occlusions in the right proximal sfa, right popliteal artery, and right posterior tibial artery.On the same day, rotational atherectomy was performed in the entire right sfa and popliteal artery.Post intervention there were diffused plaque and thrombus present in the stented segment so to additional stents were placed, a 6x200 mm and 7.0x200 mm, overlapping each other.The stents were post dilated with 6.0 x 220 mm balloon and popliteal artery was additionally treated with ballooning with 6.2 x 220 mm balloon.The posterior tibial artery and tibioperoneal trunk were treated with serial inflations of 3.0 x 80 mm balloon.Post intervention, superficial femoral artery at the site of stent deployment was patent, 10-20% residual stenosis in the posterior tibial artery and 20% residual stenosis in the popliteal artery.
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