Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatments endeavor resolute or resolute integrity (medtronic), export aspiration catheter, endeavor resolute or resolute integrity (medtronic)
Phase phase 4
Sponsor Ajou University School of Medicine
Collaborator Medtronic
Start date March 2009
End date March 2014
Trial size 1400 participants
Trial identifier NCT01156662, ETAMI-2009

Summary

The present study was designed to investigate whether the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary percutaneous coronary intervention (PCI) in acute myocardial infarction improve clinical outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
endeavor resolute or resolute integrity (medtronic) Endeavor resolute or Resolute integrity (Medtronic)
PCI without thrombus aspiration
(Active Comparator)
export aspiration catheter, endeavor resolute or resolute integrity (medtronic) Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
PCI after thrombus aspiration

Primary Outcomes

Measure
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
time frame: 12 months after index procedure

Secondary Outcomes

Measure
All-cause Death
time frame: 1 month until 12 months after index procedure
Cardiac death
time frame: 1 month until 12 months after index procedure
Myocardial infarction(Q or non-Q)
time frame: 1 month until 12 months after index procedure
Stent thrombosis by Academic Research Consortium definition
time frame: 1 month until 12 months after index procedure
Target vessel revascularization (clinically- and ischemia-driven)
time frame: 1 month until 12 months after index procedure
Target lesion revascularization (clinically- and ischemia-driven)
time frame: 1 month until 12 months after index procedure
Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
time frame: Day 0 (during PCI procedure)
Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
time frame: Day 0 (during PCI procedure)
Left ventricular wall motion improvement
time frame: 12 months
ST segment resolution on ECG after procedure
time frame: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset - Patients who are eligible for PCI Exclusion criteria - History of bleeding diathesis or coagulopathy - Pregnant - Known hypersensitivity or contra-indication to contrast agent - Left main disease - In-stent restenosis lesion - Graft vessels lesion - Chronic total occlusion lesion - Renal dysfunction, creatinine more than 2.0 mg/dL - Contraindication to aspirin, clopidogrel or cilostazol - Prior PCI or bypass surgery - Old myocardial infarction

Additional Information

Official title Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Principal investigator Seung-Jea Tahk, MD, PhD
Description Primary percutaneous coronary intervention (PCI) is the preferred strategy for immediate revascularization in patients with acute ST-elevation myocardial infarction (STEMI). A meta-analysis of trials comparing primary PCI to fibrinolytic therapy showed a mortality benefit to the invasive approach. However, although TIMI III flow is achieved in the culprit epicardial vessel in the majority of patients, lack of tissue-level reperfusion is observed in approximately 30% of patients as manifested by persistence of chest pain and ST-segment elevation. Many strategies have tried to overcome this problem, from mechanical thrombectomy and distal protection devices to myocardial preserving agents. The purpose of present study is to investigate the efficacy of the thrombus aspiration using Export Aspiration Catheter (Medtronic Corporation, California, USA) during primary PCI in acute myocardial infarction.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Ajou University School of Medicine.