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

NCT ID: NCT01156662

Last Updated: 2013-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No aspiration

Group Type: ACTIVE_COMPARATOR

Endeavor resolute or Resolute integrity (Medtronic)

Intervention Type: DEVICE

PCI without thrombus aspiration

Thrombus aspiration

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

PCI after thrombus aspiration

Interventions

Endeavor resolute or Resolute integrity (Medtronic)

PCI without thrombus aspiration

Intervention Type: DEVICE

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

PCI after thrombus aspiration

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Seung-Jea Tahk

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung-Jea Tahk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center

Locations

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

Countries

South Korea

Other Identifiers

ETAMI-2009

Identifier Type: -

Identifier Source: org_study_id