Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study
TAPAS II
1 other identifier
interventional
540
1 country
1
Brief Summary
In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedNovember 13, 2009
November 1, 2009
3.5 years
November 6, 2009
November 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of myocardial blush grade 3 after PCI
During PCI procedure
Secondary Outcomes (5)
Coronary angiographic outcomes
During PCI procedure
Histopathological outcomes of atherothrombotic material
After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius)
Enzymatic infarct size
During hospital stay
Electrocardiographic outcomes
30 to 60 minutes after PCI
Clinical outcomes at 30 days and 1 year
30 days till 1 year
Study Arms (2)
Conventional percutaneous coronary intervention
ACTIVE COMPARATORThrombus aspiration
EXPERIMENTALInterventions
Export aspiration catheter 6F (Medtronics)
balloon angioplasty and/or stent implantation
Eligibility Criteria
You may qualify if:
- Diagnosis of acute NSTEMI defined by
- Chest pain suggestive for myocardial ischemia for at least 30 minutes,
- Time from onset of symptoms of less than 72 hours
- ECG with ST-segment shifts (depression of \>0.1 mV in at least two contiguous leads or transient ST-segment elevation \>0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of \>0.15 mV in at least two contiguous leads)
- Positive cardiac troponin T \>0,01 μg/L.
- Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography
You may not qualify if:
- Persistent ST-elevation of more than 0.1 mV in 2 or more leads
- Presence of cardiogenic shock
- Inability to obtain informed consent
- Known existence of a life-threatening disease with a life expectancy of less than 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Netherlands Heart Foundationcollaborator
Study Sites (1)
University Medical Center Groningen
Groningen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 13, 2009
Study Start
December 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2012
Last Updated
November 13, 2009
Record last verified: 2009-11