Non-ST-Elevation Myocardial Infarction Clinical Trial
Official title:
Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).
The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial
infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion
and clinical outcome compared to conventional primary percutaneous coronary intervention
(PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial
perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic
material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The
aim of this study is to determine whether thrombus aspiration before stent implantation will
result in improved myocardial perfusion in patients with NSTEMI compared to conventional
PCI.
The study is a single-centre, prospective, randomised trial with blinded evaluation of
endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for
urgent PCI.
If thrombus aspiration leads to significant improvement of myocardial perfusion in patients
with acute NSTEMI it may become part of the standard interventional approach.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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