Comparison of the ABSORB TM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction - ABSORB STEMI: the TROFI II Study

ECRI B.V.0 个研究点目标入组 64 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Subject must be at least 18 years of age;
•2. Primary PCI within 24 hours of symptom onset;
•3. ST-segment elevation of > 1mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >1mm in >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 within planned device deployment segment (Dmax) by visual estimation of * 2.5 mm and * 3.8 mm;
•5. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 6 months following the index procedure.

•1. Inability to provide informed consent;
•2. Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization;
•3. Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material;
•4. Cardiogenic Shock;
•5. Unprotected left main coronary artery stenosis;
•6. Distal occlusion of target vessel;
•7. Acute myocardial infarction secondary to stent thrombosis;
•8. Mechanical complications of acute myocardial infarction;
•9. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter;
•10. Fibrinolysis prior to PCI;
•11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy;
•12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

发起方

ECRI B.V.