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AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT00275990
First received: January 10, 2006
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG [ Time Frame: 30 minutes post procedure ] [ Designated as safety issue: No ]
  • Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count [ Time Frame: post-procedure ] [ Designated as safety issue: No ]
  • 30 days- Technetium Tc 99m sestamibi infarct size, MACE [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
  • 6 months- MACE [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • 12 months- MACE [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275990

Locations
Italy
Careggi Hospital, Division of Cardiology
Florence, Italy
Sponsors and Collaborators
MEDRAD, Inc.
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: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT00275990     History of Changes
Other Study ID Numbers: JETSTENT
Study First Received: January 10, 2006
Last Updated: December 19, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by MEDRAD, Inc.:
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

ClinicalTrials.gov processed this record on June 18, 2013