Subjects with ST-elevation myocardial infarction will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intra-stent thrombus formations when compared to intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross sections with thrombus area \>10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG, and clinical endpoints will be collected and adjudicated. This trial is currently being registered at ClinicalTrials.gov.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
A. O. S. Giovanni Addolorata
Rome, RM, Italy
RECRUITINGThrombus area
The primary endpoint of this trial will be the post-procedural number of cross sections with thrombus area \>10% at optical coherence tomography.
Time frame: 1 week
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