A randomized comparison of acute thrombogenecity and long-term vascular healing between biodegradable -polymer (BP) versus durable polymer (DP) everolimus eluting stents in acute ST-elevation myocardial Infarction - CONNECT study

Taniwaki Masanori0 个研究点目标入组 120 人开始时间: 2019年3月20日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Age greater than or equal to 18 years
•2. Primary PCI within 24 hours of symptom onset
•3. ST-segment elevation of greater than or equal to 1mm in at least 2 contiguous leads, or (presumably new) left bundle branch block or true posterior MI with ST depression of greater than or equal to 1mm in at least 2 contiguous anterior leads
•4. Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.5 mm in diameter that can be covered with one or multiple stents
•5. Signed informed consent

•1.Female of childbearing potential (age less than 50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
•2. Known intolerance to aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, biolimus or contrast material
•3. Inability to provide informed consent
•4. Currently participating in another trial before reaching first endpoint
•5. Mechanical complications of acute myocardial infarction
•6. Acute myocardial infarction secondary to stent thrombosis or restenosis
•7. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
•8. Noncardiac comorbid conditions are present with life expectancy less than 3 years or that may result in protocol noncompliance
•9. History of bleeding diathesis or known coagulopathy
•10. Use of oral anticoagulation
•11. Age greater than or equal to 90 years
•12. LV-function at index procedure less than or equal to 20%
•13. Cancer under active treatment (chemotherapy)
•14. Hemodynamic instability following primary PCI
•15. Chronic kidney disease (estimated creatinine clearance less than 30ml/min)
•16. OCT technically not feasible (severe calcification, tortuosity)

发起方

Taniwaki Masanori