(b)(6) clinical study.It was reported that coronary artery restenosis occurred.In (b)(6) 2013, the index procedure was performed.The target lesion was a de novo lesion located in the proximal left circumflex (lcx) artery with 95% stenosis and was 6mm long with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50x8mm study stent with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient presented to the hospital with symptoms of shortness of breath and dizziness on exertion that would be relieved by rest.The patient underwent a stress study that was abnormal, revealing ischemia in the anterior and inferior walls suggestive of coronary artery disease.The patient was further referred for cardiac catheterization to rule out obstructive coronary artery disease.The following day, coronary angiography was performed.On the same day, the 99% calcified stenosis located in the proximal lcx was treated with balloon angioplasty and placement of a 3.5x38mm synergy stent.Post procedure, the stenosis was 0% with timi 3 flow.There were no post procedural complications noted.The following day, the event was considered as resolved.
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