AngioJET Thrombectomy and STENTing for Treatment of Acute Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Device: direct stenting; Device: rheolytic thrombectomy with direct stenting

• Registration Number: NCT00275990
• Lead Sponsor: Boston Scientific Corporation

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Primary Completion: 2009-10
• Study Completion: 2010-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
directing stenting alone	direct stenting	directing stenting alone
thrombectomy before stenting	rheolytic thrombectomy with direct stenting	thrombectomy before stenting

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
12 months- MACE	12 months post-procedure
Post-procedure- TIMI flow, TIMI myocardial blush, and corrected TIMI frame count	post-procedure
6 months- MACE	6 months post-procedure
30 days- Technetium Tc 99m sestamibi infarct size, MACE	30 days post-procedure

Trial Locations

Locations (1)

Careggi Hospital, Division of Cardiology; 🇮🇹 Florence, Italy