Acute Myocardial InfarctionPhase 4ETAMINCT01156662
Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
A Phase 4 study testing Endeavor resolute or Resolute integrity (Medtronic) and Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) in people with Acute Myocardial Infarction, run by Ajou University School of Medicine at 27 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Endeavor resolute or Resolute integrity (Medtronic) and Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 27 sitesSouth Korea
- Study dates
- Mar 2009to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset
- Patients who are eligible for PCI
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
South Korea27 sites
Hallym University Sacred Heart Hospital
Anyang
Sejong General Hospital
Bucheon-si
Bundang CHA General Hospital
Bundang
Seoul National University Bundang Hospital
Bundang
Dankook University Hospital
Cheonan
Soon Chun Hyang University Hospital
Cheonan
Keimyung University Dongsan Hospital
Daegu
Yeungnam University Medical Center
Daegu
Daejeon ST. Mary's Hospital,The Catholic University of Korea
Daejeon
Konyang University Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Kwandong University college of Medicine Myongji Hospital
Goyang
National Health Insurance Corporation ILSAN Hospital
Goyang
Chonnam National University Hospital
Gwangju
Inha University Hospital
Incheon
Chonbuk National University Hospital
Jeonju
Handong University Sunlin Hospital
Pohang
Inje University Pusan Paik Hospital
Pusan
Hallym University Kangdong Sacred Heart Hospital
Seoul
Hallym University Kangnam Sacred Heart Hospital
Seoul
Korea Univeristy Guro Hospital
Seoul
Yonsei University Gangnam Severance Hospital
Seoul
Yonsei University Severance Hospital
Seoul
St. Carollo Hospital
Suncheon
Ajou University Hospital
Suwon
Ulsan University Hospital
Ulsan
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wŏnju
About this study
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.
Read the 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
- Being tested
- Endeavor resolute or Resolute integrity (Medtronic), Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)
- Keywords
- Thrombus aspiration, Percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor resolute or Resolute integrity (Medtronic)Device
PCI without thrombus aspiration
Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)Device
PCI after thrombus aspiration
| Study group | Role | What they receive |
|---|---|---|
| No aspiration | Active comparator | Not described Receives: Device: Endeavor resolute or Resolute integrity (Medtronic) |
| Thrombus aspiration | Active comparator | Not described Receives: Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
Measured: 12 months after index procedure
Secondary outcomes (10)
All-cause Death
Measured: 1 month until 12 months after index procedure
Cardiac death
Measured: 1 month until 12 months after index procedure
Myocardial infarction(Q or non-Q)
Measured: 1 month until 12 months after index procedure
Stent thrombosis by Academic Research Consortium definition
Measured: 1 month until 12 months after index procedure
Target vessel revascularization (clinically- and ischemia-driven)
Measured: 1 month until 12 months after index procedure
Target lesion revascularization (clinically- and ischemia-driven)
Measured: 1 month until 12 months after index procedure
Post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade
Measured: Day 0 (during PCI procedure)
Post-procedural Thrombolysis in Myocardial Infarction Myocardial Perfusion (TMP) grades
Measured: Day 0 (during PCI procedure)
Left ventricular wall motion improvement
Measured: 12 months
ST segment resolution on ECG after procedure
Measured: 0 hour (at the end of procedure), 1 hour, and 24 hours after PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Seung-Jea Tahk, Ajou University School of Medicine
- Investigators
- Seung-Jea Tahk, MD, PhD, Principal investigator, Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156662
- Sponsor's protocol ID
- ETAMI-2009
- Acronym
- ETAMI
- Status last verified
- Apr 2013
- First submitted
- 1 Jul 2010
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Thrombosuction in Primary Percutaneous Coronary Intervention of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01156662
- Acronym / sponsor ID
- ETAMI / ETAMI-2009
- Conditions
- Acute Myocardial Infarction
- Keywords
- Thrombus aspiration, Percutaneous coronary intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2009
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No aspiration | Active comparator | Device: Endeavor resolute or Resolute integrity (Medtronic) |
| Thrombus aspiration | Active comparator | Device: Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with first ST-elevation myocardial infarction who undergo primary PCI within 12 hours after symptom onset
- Patients who are eligible for PCI
Key exclusion criteria (11 listed)
- History of bleeding diathesis or coagulopathy
- Pregnant
- Known hypersensitivity or contra-indication to contrast agent
- Left main disease
- In-stent restenosis lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endeavor resolute or Resolute integrity (Medtronic)PCI without thrombus aspiration | Device | No aspiration |
| Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)PCI after thrombus aspiration | Device | Thrombus aspiration |
Primary outcome
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization
Time frame: 12 months after index procedure
10 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jea Tahk, MD, PhD principal investigator
Department of Cardiology, Ajou University School of Medicine, Ajou University Medical Center
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endeavor resolute or Resolute integrity (Medtronic) and Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic) in people with Acute Myocardial Infarction, run by Ajou University School of Medicine at 27 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of cardiac death, Q-wave myocardial infarction, and target vessel revascularization (time frame: 12 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.