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AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275990
First Posted: January 12, 2006
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose
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).

Condition Intervention Phase
Myocardial Infarction Device: rheolytic thrombectomy with direct stenting Device: direct stenting Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients Undergoing Primary PCI for Acute Myocardial Infarction: [JETSTENT] Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 501
Study Start Date: December 2005
Study Completion Date: August 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: thrombectomy before stenting
thrombectomy before stenting
Device: rheolytic thrombectomy with direct stenting
Active Comparator: directing stenting alone
directing stenting alone
Device: direct stenting

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275990


Locations
Italy
Careggi Hospital, Division of Cardiology
Florence, Italy
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David Antoniucci, MD Azienda Ospedaliero-Universitaria Careggi, Florence, ITALY
Principal Investigator: Antonio Colombo, MD San Raffaelle Hospital, Milan ITALY
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00275990     History of Changes
Other Study ID Numbers: JETSTENT
First Submitted: January 10, 2006
First Posted: January 12, 2006
Last Update Posted: October 9, 2014
Last Verified: October 2014

Keywords provided by Boston Scientific Corporation:
coronary thrombectomy
thrombectomy for acute myocardial infarction
C14.280.647.500
C14.907.553.355.500

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases