NL-OMON35318
Completed
Phase 3
A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction - INFUSE AMI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Atrium Medical Corporation
- Enrollment
- 50
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- \>\= 18 years of age;
- •\- Anterior MI with ECG showing at least 1 mm of ST\-segment elevation in 2 or more contiguous leads in V1\-V4, or new (or presumably new) left bundle branch block;
- •\- Anticipated symptom onset to balloon or aspiration time of \<\= 5 hours;
- •\- Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0, 1 or 2 flow at the time of initial diagnostic angiography (prior to wire passage);
- •\- Based on coronary anatomy, PCI is indicated for revascularization;
- •\- Only one epicardial coronary artery will be treated;
- •\- Expected ability to deliver a ClearWay\* RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).
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;
- •\- Any contraindication to undergo MRI imaging.
- •\- Coronary anatomy such that coronary artery bypass graft surgery will possibly be required within 30 days;
- •\- Multivessel intervention required during the index procedure
- •\- Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the Clearway Catheter
- •\- Subjects who have prior history of bypass surgery (CABG);
- •\- MI is due to thrombosis within or adjacent to a previously implanted stent;
Outcomes
Primary Outcomes
Not specified
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