Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
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|ClinicalTrials.gov Identifier: NCT01013038|
Recruitment Status : Unknown
Verified November 2009 by University Medical Center Groningen.
Recruitment status was: Recruiting
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Non-ST-Elevation Myocardial Infarction||Procedure: Thrombus aspiration followed by stent implantation Procedure: conventional PCI||Phase 4|
The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI.
The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.
If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||June 2012|
|Active Comparator: Conventional percutaneous coronary intervention||
Procedure: conventional PCI
balloon angioplasty and/or stent implantation
|Experimental: Thrombus aspiration||
Procedure: Thrombus aspiration followed by stent implantation
Export aspiration catheter 6F (Medtronics)
- Incidence of myocardial blush grade 3 after PCI [ Time Frame: During PCI procedure ]
- Coronary angiographic outcomes [ Time Frame: During PCI procedure ]
- Histopathological outcomes of atherothrombotic material [ Time Frame: After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius) ]
- Enzymatic infarct size [ Time Frame: During hospital stay ]
- Electrocardiographic outcomes [ Time Frame: 30 to 60 minutes after PCI ]
- Clinical outcomes at 30 days and 1 year [ Time Frame: 30 days till 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013038
|Contact: Marthe A Kampinga, MDemail@example.com|
|Contact: Felix Zijlstra, MD PhDfirstname.lastname@example.org|
|University Medical Center Groningen||Recruiting|
|Contact: Marthe A Kampinga, MD +31503610444 email@example.com|