Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Interventions
- Device: Endeavor resolute or Resolute integrity (Medtronic)Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
- Registration Number
- NCT01156662
- Lead Sponsor
- Ajou University School of Medicine
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1400
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No aspiration Endeavor resolute or Resolute integrity (Medtronic) - Thrombus aspiration Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) -
- Primary Outcome Measures
Name Time Method The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization 12 months after index procedure
- Secondary Outcome Measures
Name Time Method Stent thrombosis by Academic Research Consortium definition 1 month until 12 months after index procedure 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 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
Trial Locations
- Locations (27)
National Health Insurance Corporation ILSAN Hospital
🇰🇷Goyang, Korea, Republic of
Handong University Sunlin Hospital
🇰🇷Pohang, Korea, Republic of
Korea Univeristy Guro Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Yonsei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
🇰🇷Wonju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Bundang, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon, Korea, Republic of
Bundang CHA General Hospital
🇰🇷Bundang, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Cheonan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Daejeon ST. Mary's Hospital,The Catholic University of Korea
🇰🇷Daejeon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejon, Korea, Republic of
Kwandong University college of Medicine Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of