Myocardial Infarction Clinical Trial
Official title:
AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study
The purpose of this study is to determine whether prompt removal of thrombus (blood clot) from a blocked coronary artery using the AngioJet rheolytic thrombectomy device will result in improved blood flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).
Occlusive thrombosis triggered by a disrupted or eroded atherosclerotic plaque is the
anatomic substrate of most acute myocardial infarctions (AMI). Macro- and microembolization
of thrombus during percutaneous coronary intervention (PCI) in AMI is frequent and may
result in obstruction of the microvessel network, and decreased efficacy of reperfusion and
myocardial salvage. Direct stenting without predilation or postdilation is the most
simplistic approach to the problem of embolization, and may decrease embolization and the
incidence of the no-reflow phenomenon. Other approaches to the problem of microvessel
embolization include percutaneous rheolytic thrombectomy (RT) with the AngioJet catheter
before stent implantation. The objectives of the study are: to assess whether RT before
direct infarct artery stenting results in improved reperfusion success in patients with
acute ST-segment elevation myocardial infarction (STEMI) and angiographically evident
thrombus; and to validate a technique for use of the AngioJet RT catheter in the treatment
of STEMI.
Comparisons: Treatment with AngioJet RT immediately before direct infarct artery stenting
versus direct stenting alone, in patients with STEMI and angiographically visible thrombus
presenting within 6 hours of symptom onset for primary PCI.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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