Agent ide study.It was reported that angina and in-stent restenosis occurred.On (b)(6) 2020, a 3.00 mm x 8 mm synergy stent was implanted in the proximal left circumflex artery (lcx) and a 3.00 x 12mm synergy stent was implanted in the proximal rca.On (b)(6) 2020, severe in-stent restenosis (isr) was noted in the proximal rca.A 2.75 x 28mm synergy stent and a 2.75 x 12mm synergy stent were implanted in the proximal to mid rca to treat the restenosis.On (b)(6) 2021, the subject presented with stable angina and was randomized into the agent ide study and index procedure was performed the same day.Heparin or other antithrombotic medication were administered at the time of index procedure.The isr of the 3.0 x 8mm synergy stent at the proximal lcx was treated with balloon angioplasty.On the same day, the 3.00 x 10mm isr of the mid rca (where the 2.75 x 28mm synergy and 2.75 x 12mm synergy stents were located) was also treated.The target lesion was predilated with a 2.5 mm x 15 mm balloon with 10% residual stenosis and timi flow 3.Following pre-dilation, the lesion was successfully treated with 3.50 mm x 12 mm study device with 10% residual stenosis and timi flow 3.Post dilation was not performed.The subject experienced confusion, diarrhea, acute kidney injury, metabolic acidosis, and vertigo not considered related to the devices.On 2 sep 2021, the subject was discharged on aspirin and clopidogrel.
|