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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
501
Careggi Hospital, Division of Cardiology
Florence, Italy
ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG
Time frame: 30 minutes post procedure
Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days
Time frame: 30 days post-procedure
Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count
Time frame: post-procedure
30 days- Technetium Tc 99m sestamibi infarct size, MACE
Time frame: 30 days post-procedure
6 months- MACE
Time frame: 6 months post-procedure
12 months- MACE
Time frame: 12 months post-procedure
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