A postmarket surveillance registry of the BioMatrix drug eluting stent in diabetic patients. - EBMX(PMD)

Biosensors Europe SA Morges Switzerland0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients must be previously diagnosed with Type I or Type II diabetes with documented treatment with insulin or oral hypoglycemics by medical history. Undocumented or newly diagnosed diabetics must have either blood sugar fasting value of more than 115 mg per dl, post meal 140 mg per dl or glycosylated hemoglobin more than 7.3 percentage (if applicable)
•2. Patients that need a treatment with a BioMatrix drug-eluting stent
•3. Presence of one or more coronary artery stenoses in a native coronary artery, saphenous bypass graft, or radial vein graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
•3. No limitation on the number of treated lesions, and vessels, and lesion length.

•1. Inability to provide informed consent
•2. Patients needing additional stent NOT of the Biolimus A9-eluting stent type
•3. Patients receiving next to the Biolimus A9-eluting stent also other coronary vascular interventions, for example dilation
•4. Patients admitted for treatment of diabetic ketoacidosis 2 times in the past six months (Brittle Diabetics)

发起方

Biosensors Europe SA Morges Switzerland