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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No aspiration | Active Comparator |
| |
| Thrombus aspiration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endeavor resolute or Resolute integrity (Medtronic) | Device | PCI without thrombus aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization | 12 months after index procedure |
| 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) |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Jea Tahk, MD, PhD | Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | South Korea | ||||
| Sejong General Hospital |
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| Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) | Device | PCI after thrombus aspiration |
|
| 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 |
| Bucheon-si |
| South Korea |
| Bundang CHA General Hospital | Bundang | South Korea |
| Seoul National University Bundang Hospital | Bundang | South Korea |
| Dankook University Hospital | Cheonan | South Korea |
| Soon Chun Hyang University Hospital | Cheonan | South Korea |
| Keimyung University Dongsan Hospital | Daegu | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Daejeon ST. Mary's Hospital,The Catholic University of Korea | Daejeon | South Korea |
| Konyang University Hospital | Daejeon | South Korea |
| Gangneung Asan Hospital | Gangneung | South Korea |
| Kwandong University college of Medicine Myongji Hospital | Goyang | South Korea |
| National Health Insurance Corporation ILSAN Hospital | Goyang | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Handong University Sunlin Hospital | Pohang | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Hallym University Kangdong Sacred Heart Hospital | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Korea Univeristy Guro Hospital | Seoul | South Korea |
| Yonsei University Gangnam Severance Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| St. Carollo Hospital | Suncheon | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital | Wŏnju | South Korea |