It was reported that in-stent thrombosis occurred.The patient underwent treatment with the eluvia trial device on (b)(6) 2018 as part of the regal clinical trial.The 100% stenosed target lesion was located in the right distal and proximal superficial femoral artery (sfa) that was 240mm in length with 6mm reference vessel diameter, proximally and distally.Pre-dilatation was performed using one balloon.Afterwards three eluvia, two 6x120 and one 6x80, stents were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019 an in-stent thrombosis of the three stents within the right sfa was detected.The patient was hospitalized on (b)(6) 2019 and percutaneous transluminal angioplasty and thrombolysis were performed.The re-intervention was located at the distal end of the sfa to the start of the proximal popliteal artery (ppa).The patient was discharged from the hospital on (b)(6) 2019 and the event was considered resolved.
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