eo-Registry:Observational retrospective study to Determine safety and performance of (NeoHexa)Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one year follow-Up Period

Sahajanand Laser Technology Ltd0 个研究点目标入组 129 人开始时间: 待定最近更新: 2021年11月24日

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•1. Males and Females more than 18 years of age.
•2. Subjects who had signed the Hospital consent form.
•3. The subjects who have been treated with PCI and implantated with Neohexa Drug Eluting Stent as a part of their treatment of Coronary Artery Disease, without any further indication for Emergent Coronary Artery Bypass Graft Surgery.

•1.Subjects who were not eligible for a PCI procedure. Or who were candidates for Urgent or planned elective Coronary Artery Bypass Surgery.
•2. Subjects who are treated with stents other than Neohexa stent.
•3. Subjects who are known sensitive to Cobalt Chromium alloy,PLLA Polymer, Sirolimus and its Analogues, Aspirin, Clopidogrel and analogues, and Contrast media.
•4. Pregnant/lactating women during Index procedure. However,if pregnancy occurs during followâ??ups, the subject will not be excluded.
•5. Subjects with more than Grade III Renal Insufficiency as indicated by Creatinine > 160 mcmol/L.
•6. Subjects with short life expectancy less than the trial duration of 1 years (including patients with cancer, HIV/AIDS),documented LVEF <30%, history of Cardiac Failure, Structural
•heart disease, Myocardiopathies, Arrhythmia or other Comorbid conditions.

发起方

Sahajanand Laser Technology Ltd