AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275990
• Other study ID #: JETSTENT
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2006
• Last updated: October 8, 2014
• Start date: December 2005
• Est. completion date: August 2010

Study information

• Verified date: October 2014
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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 flow within the heart and a smaller final infarct size (reduced injury to the heart muscle).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: August 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Device:
• rheolytic thrombectomy with direct stenting

• direct stenting

Locations

Country	Name	City	State
Italy	Careggi Hospital, Division of Cardiology	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Antoniucci D, Valenti R, Migliorini A, Parodi G, Memisha G, Santoro GM, Sciagrà 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. — View Citation

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 dire — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST-segment resolution at 30 minutes post-PCI, assessed by 12-lead ECG		30 minutes post procedure	No
Primary	Infarction size measured by technetium Tc 99m sestamibi imaging at 30 days		30 days post-procedure	No
Secondary	Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count		post-procedure	No
Secondary	30 days- Technetium Tc 99m sestamibi infarct size, MACE		30 days post-procedure	No
Secondary	6 months- MACE		6 months post-procedure	No
Secondary	12 months- MACE		12 months post-procedure	No