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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thrombectomy before stenting | Experimental | thrombectomy before stenting |
|
| directing stenting alone | Active Comparator | directing stenting alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rheolytic thrombectomy with direct stenting | Device |
| ||
| direct stenting |
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Antoniucci, MD | Azienda Ospedaliero-Universitaria Careggi, Florence, ITALY | Principal Investigator |
| Antonio Colombo, MD | San Raffaelle Hospital, Milan ITALY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Careggi Hospital, Division of Cardiology | Florence | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15081450 | Background | Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagra R. Comparison of rheolytic thrombectomy before direct infarct artery stenting versus direct stenting alone in patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2004 Apr 15;93(8):1033-5. doi: 10.1016/j.amjcard.2004.01.011. | |
| 20691553 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Device |
|
| 6 months- MACE |
| 6 months post-procedure |
| 12 months- MACE | 12 months post-procedure |
| Migliorini A, Stabile A, Rodriguez AE, Gandolfo C, Rodriguez Granillo AM, Valenti R, Parodi G, Neumann FJ, Colombo A, Antoniucci D; JETSTENT Trial Investigators. Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial. J Am Coll Cardiol. 2010 Oct 12;56(16):1298-306. doi: 10.1016/j.jacc.2010.06.011. Epub 2010 Aug 5. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |