Vascular Response in Patients with Diabetes Mellitus: An Optical Coherence Tomography Study of Ultrathin Strut Biodegradable Polymer-coated Sirolimus-eluting Stent

niversal Cardiovascular Research Foundation0 个研究点目标入组 0 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. Patient must be at least 18 years of age
•2. Patient with symptomatic coronary artery disease
•3. Stable patients with diabetes mellitus
•4. Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure
•5. Able to understand and sign the written informed consent form
•6. Able and willing to follow the protocol requirements

•1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure
•2. Life expectancy <12 months due to another medical condition
•3. Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds
•4. Creatinine level more than 2.0 mg/dL or ESRD
•5. Severe hepatic dysfunction (more than 3 times normal reference values)
•6. Planned surgery procedure <=3 months post-index procedure
•7. Known allergy to cobalt-chromium
•8. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 3 months post index procedure
•9. No suitable anatomy for OCT scan in the opinion of investigator

发起方

niversal Cardiovascular Research Foundation