Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction (ETAMI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01156662
First received: July 1, 2010
Last updated: April 13, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Device: Endeavor resolute or Resolute integrity (Medtronic)
Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization [ Time Frame: 12 months after index procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All-cause Death [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: Yes ]
  • Myocardial infarction(Q or non-Q) [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis by Academic Research Consortium definition [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: No ]
  • Target lesion revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ] [ Designated as safety issue: No ]
  • Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade [ Time Frame: Day 0 (during PCI procedure) ] [ Designated as safety issue: No ]
  • Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades [ Time Frame: Day 0 (during PCI procedure) ] [ Designated as safety issue: No ]
  • Left ventricular wall motion improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • ST segment resolution on ECG after procedure [ Time Frame: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: March 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No aspiration Device: Endeavor resolute or Resolute integrity (Medtronic)
PCI without thrombus aspiration
Other Name: Endeavor resolute or Resolute integrity (Medtronic)
Active Comparator: Thrombus aspiration Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
PCI after thrombus aspiration
Other Name: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156662

Locations
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
Seoul National University Bundang Hospital
Bundang, Korea, Republic of
Dankook University Hospital
Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital
Cheonan, Korea, Republic of
Yeungnam University Medical Center
Daegu, 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
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Kwandong University college of Medicine Myongji Hospital
Goyang, Korea, Republic of
National Health Insurance Corporation ILSAN Hospital
Goyang, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Handong University Sunlin Hospital
Pohang, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Yonsei University Gangnam Severance Hospital
Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Korea Univeristy Guro Hospital
Seoul, Korea, Republic of
St. Carollo Hospital
Suncheon, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Medtronic
Investigators
Principal Investigator: Seung-Jea Tahk, MD, PhD Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jea Tahk, Dr., Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01156662     History of Changes
Other Study ID Numbers: ETAMI-2009
Study First Received: July 1, 2010
Last Updated: April 13, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Ajou University School of Medicine:
Thrombus aspiration
Percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014