Myocardial Infarction
Conditions
Keywords
coronary thrombectomy, thrombectomy for acute myocardial infarction, C14.280.647.500, C14.907.553.355.500
Brief summary
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).
Detailed description
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.
Interventions
DEVICErheolytic thrombectomy with direct stenting
DEVICEdirect stenting
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age \> 18 years * ST-segment elevation myocardial infarction * Angiographically visible thrombus * Presentation within 6 hours of symptom onset for primary percutaneous coronary intervention * Patient, or relative or legal guardian,provides written informed consent * Patient has no childbearing potential or is not pregnant
Exclusion criteria
* Prior administration of thrombolysis for current MI * Participation in another Study * Major surgery within past 6 weeks * History of stroke within 30 days, or any history of hemorrhagic stroke * Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy * Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3) * Known prior history of renal insufficiency * Co-morbidities with expected survival \< 1 year * Patient unwilling to receive blood products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG | 30 minutes post procedure |
| Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days | 30 days post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count | post-procedure |
| 30 days- Technetium Tc 99m sestamibi infarct size, MACE | 30 days post-procedure |
| 6 months- MACE | 6 months post-procedure |
| 12 months- MACE | 12 months post-procedure |
Countries
Italy
Outcome results
None listed