(b)(6) clinical study.It was reported that restenosis of the implanted stent occurred.The patient was enrolled in the (b)(6) clinical study.On (b)(6) 2017, the index procedure was performed.The target lesion was located in the left superficial femoral artery (sfa).The lesion had a 5mm reference vessel diameter proximal and distal, and a total length of 120mm visually estimated.The target lesion was 100% occluded and crossed through a true lumen.A balloon was used for pre-dilation, after which a 6mm x 150mm study stent was implanted.Another balloon was used for post-dilation and the residual stenosis was 5%.On (b)(6) 2019, in-stent restenosis of the left sfa was observed and the patient was hospitalized.An in-stent percutaneous transluminal angioplasty (pta) was performed.In addition, the stenting of two popliteal lesions was performed.The event was reported as resolved as of (b)(6) 2019.
|