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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Seung-Jea Tahk, Ajou University School of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156662
First Posted: July 5, 2010
Last Update Posted: April 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
July 1, 2010
July 5, 2010
April 16, 2013
March 2009
March 2014   (Final data collection date for primary outcome measure)
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization [ Time Frame: 12 months after index procedure ]
Same as current
Complete list of historical versions of study NCT01156662 on ClinicalTrials.gov Archive Site
  • All-cause Death [ Time Frame: 1 month until 12 months after index procedure ]
  • Cardiac death [ Time Frame: 1 month until 12 months after index procedure ]
  • Myocardial infarction(Q or non-Q) [ Time Frame: 1 month until 12 months after index procedure ]
  • Stent thrombosis by Academic Research Consortium definition [ Time Frame: 1 month until 12 months after index procedure ]
  • Target vessel revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ]
  • Target lesion revascularization (clinically- and ischemia-driven) [ Time Frame: 1 month until 12 months after index procedure ]
  • Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade [ Time Frame: Day 0 (during PCI procedure) ]
  • Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades [ Time Frame: Day 0 (during PCI procedure) ]
  • Left ventricular wall motion improvement [ Time Frame: 12 months ]
  • ST segment resolution on ECG after procedure [ Time Frame: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure ]
Same as current
Not Provided
Not Provided
 
Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Device: Endeavor resolute or Resolute integrity (Medtronic)
    PCI without thrombus aspiration
  • Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
    PCI after thrombus aspiration
  • Active Comparator: No aspiration
    Intervention: Device: Endeavor resolute or Resolute integrity (Medtronic)
  • Active Comparator: Thrombus aspiration
    Intervention: Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1400
April 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01156662
ETAMI-2009
Yes
Not Provided
Not Provided
Seung-Jea Tahk, Ajou University School of Medicine
Ajou University School of Medicine
Medtronic
Principal Investigator: Seung-Jea Tahk, MD, PhD Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
Ajou University School of Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP