Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction (ETAMI)

Ajou University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Acute Myocardial Infarction

Treatments: Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic); Device: Endeavor resolute or Resolute integrity (Medtronic)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01156662

ETAMI-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,400 participants in 2 patient groups

No aspiration

Active Comparator group

Treatment:

Device: Endeavor resolute or Resolute integrity (Medtronic)

Thrombus aspiration

Active Comparator group

Treatment:

Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)