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 Infarctio
- Conditions
- Acute Myocardial Infarction1001108210003216
- Registration Number
- NL-OMON35318
- Lead Sponsor
- Atrium Medical Corporation
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
- >= 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).
- 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;
- Left ventriculography demonstrates severe mitral regurgitation or a VSD;
- Unprotected left main stenosis >40% or that will require intervention;
- Subject has received >5000 units of unfractionated heparin within the preceding 24 hours prior to presenting to the catheterization laboratory, or any subject who receives heparin after arrival in the cardiac catheterization laboratory prior to randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Infarct size (percentage of total LV mass) at 30 days (range -7 days/+14 days;<br /><br>i.e., between 23 to 44 days) measured by cardiac MRI, comparing the pooled<br /><br>randomized active (abciximab) infusion (with or without thrombus aspiration) to<br /><br>the pooled non infusion arms (with or without thrombus aspiration).<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method