NCT01013038

Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study

Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Non-ST-Elevation Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Thrombus aspiration followed by stent implantation	Export aspiration catheter 6F (Medtronics)
PROCEDURE	conventional PCI	balloon angioplasty and/or stent implantation

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2009-11-13
• Last updated: 2009-11-13

Locations

1 site across 1 country: Netherlands