Status:
COMPLETED
AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00275990
Start Date
December 1 2005
End Date
August 1 2010
Last Update
October 9 2014
Active Locations (1)
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1
Careggi Hospital, Division of Cardiology
Florence, Italy