Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
ETAMI
1 other identifier
interventional
1,400
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Longer than P75 for phase_4
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 16, 2013
April 1, 2013
5 years
July 1, 2010
April 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
12 months after index procedure
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
No aspiration
ACTIVE COMPARATORThrombus aspiration
ACTIVE COMPARATORInterventions
PCI without thrombus aspiration
PCI after thrombus aspiration
Eligibility Criteria
You may qualify if:
- Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset
- Patients who are eligible for PCI
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ajou University School of Medicinelead
- Medtroniccollaborator
Study Sites (27)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Sejong General Hospital
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
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jea Tahk, MD, PhD
Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 5, 2010
Study Start
March 1, 2009
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
April 16, 2013
Record last verified: 2013-04