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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

July 1, 2010
April 13, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Device: Endeavor resolute or Resolute integrity (Medtronic)
    PCI without thrombus aspiration
    Other Name: Endeavor resolute or Resolute integrity (Medtronic)
  • 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)
  • 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.
 
Active, not recruiting
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01156662
ETAMI-2009
Yes
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