Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: Endeavor resolute or Resolute integrity (Medtronic)
* Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No aspiration<br> | Device: Endeavor resolute or Resolute integrity (Medtronic)<br>* PCI without thrombus aspiration<br>|
| Active Comparator: Thrombus aspiration<br> | Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)<br>* PCI after thrombus aspiration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization |  | 12 months after index procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombus aspiration, Percutaneous coronary intervention