AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: rheolytic thrombectomy with direct stenting
* Device: direct stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thrombectomy before stenting<br>thrombectomy before stenting | Device: rheolytic thrombectomy with direct stenting<br> <br> |
| Active Comparator: directing stenting alone<br>directing stenting alone | Device: direct stenting<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 6 months- MACE |  | 6 months post-procedure | 
| 12 months- MACE |  | 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary thrombectomy, thrombectomy for acute myocardial infarction, C14.280.647.500, C14.907.553.355.500