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EXPORT Study First Report - Clinical Trial Results:出口研究的首次报告临床试验的结果
EXPORT STUDYFirst Report TCT 2007 Bernard Chevalier, Keyur Parikh, Martine Gilard, Irene Lang On behalf of the study investigators EXPORT Study To evaluate flow improvement in patients with Acute Myocardial Infarction undergoing either conventional stenting or a strategy of primary aspiration followed by stenting using the ExPORT? Aspiration Catheter in patients presenting with Acute Myocardial Infarction EXPORT Study CE Mark and FDA approved device, with the following indication for use in central and peripheral circulatory system: Contain and aspirate embolic material (thrombus/debris) while performing transluminal angioplasty or stenting procedures To sub selectively infuse/deliver diagnostic or therapeutic fluids. Background Hypothesis: if a technique reduces by 33% the risk of no-reperfusion (basis: Claeys et al.) Hard endpoint: mortality 6.7% versus 5.1% …7056 patients Background Background Background Background Blush 0 No appearance of blush or opacification of the myocardium Blush 1 Presence of blush but no clearance of contrast (stain is present on the next injection) Blush 2 Blush clears slowly – clears minimally or not at all during three cardiac cycles Blush 3 Blush begins to washout and is only minimally persistent after three cardiac cycles Background Background EXPORT Study EXPORT Study EXPORT Study Main Inclusion Criteria ST-segment elevation of ? 2 mm in ? 2 contiguous leads De novo lesions in mid or proximal segments of native coronary vessels A visual estimated reference vessel diameter ? 2.5 mm TIMI flow of 0 or 1 before wiring Main Exclusion Criteria Pre-cathlab use of lytic therapy or IIb/IIIa antagonist Patients presenting with a cardiogenic shock (blood pressure 90 mmHg) Patients presenting with cardiac arrest at any time before intervention Patients previously treated with a pacemaker or with left/right bundle branch block Any planned use of distal protection device Multivessel coronary artery disease with planned non-target artery PCI o
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