The INFUSE - Anterior Myocardial Infarction (AMI) Study

Exclusion Criteria

• •Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction \<40% by any prior measure or regional wall motion abnormalities);
• •An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
• •Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
• •Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
• •Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
• •Any contraindication to undergo MRI imaging.
• •Multivessel intervention required during the index procedure (subjects may be enrolled if treatment of more than one lesion in the LAD or its branches is required, however) (planned staged procedures are permitted with strong recommendation to be performed after 30-day clinical and MRI endpoints are completed);
• •Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export® Aspiration Catheter;
• •Features are present highly unfavorable for PCI;
• •Target lesion is present within a bypass graft conduit;
• •MI is due to thrombosis within or adjacent to a previously implanted stent;
• •Left ventriculography demonstrates severe mitral regurgitation or a VSD;
• •Unprotected left main stenosis \>40% or that will require intervention