(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the subject presented with stable angina (ccs classification- 2).Prior to the procedure, the subject was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization.Target lesion #1 was located in the ramus with 90% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 28 mm study stent.Following post dilatation, residual stenosis was noted to be 0%.The following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2014, the patient presented with unstable angina.Rotational atherectomy was performed and two promus premier stents were implanted in the proximal to mid left anterior descending artery.In (b)(6) 2018, the subject was diagnosed with congestive heart failure and on the same day the subject died.The cause of death was due to heart failure.
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