PERFORMANCE OF BIORESORBABLE POLYMER-COATED EVEROLIMUS-ELUTING SYNERGY® STENT IN PATIENTS AT HIGH BLEEDING RISK UNDERGOING PERCUTANEOUS CORONARY REVASCULARIZATION FOLLOWED BY 1-MONTH DUAL ANTIPLATELET THERAPY - POEM

IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 1,023 人2018年9月14日

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暂无简介。

注册库

who.int

开始日期

2018年9月14日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

IRCCS ISTITUTO CLINICO HUMANITAS

•a)Written, signed informed consent;
•b)Age \=18 years;
•c)Patients at high bleeding risk (HBR) with symptomatic coronary artery disease, including patients with chronic stable angina, silent ischemia, or acute coronary syndromes (including NSTE\-ACS and STE\-ACS);
•d)Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft that treated with one or multiple Synergy® stents;
•e) PCI with the implantation of at least one Synergy® Stent System within 12 hours prior to inclusion
•Moreover, in order to be included patients will need to meet at least 1 of the following HBR criteria:
•1\.Age \=75 years
•2\.Oral anticoagulation planned to continue after PCI
•3\.Hemoglobin \<11 g/l,
•4\.Transfusion within 4 week before inclusion

•a)Cardiogenic shock
•b)Major active bleeding at the time of PCI
•c)Expected non\-adherence with 1 month DAPT
•d)Known intolerance to ASA, clopidogrel or ticagrelor or any of the excipients
•e)Currently participating in another trial
•f)Pregnancy or lactation
•Note: there will be no exclusion based on mode of clinical presentation (with the exception of cardiogenic shock), co\-morbidities, left ventricular function, number of diseased vessels and lesions, or number and type of target lesions