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news.Spectranetics has announced enrollment of the first patients in the thromboablation in acute myocardial infarction, or Taami, trial. The Taami trial is a planned 200-patient randomized trial involving major medical centers in Poland.
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Starting last quarter, Taami enrolled its first six patients and recently initiated the fifth participating hospital.
The trial comprises two treatment groups and enrolls the most complex acute myocardial infarction (AMI) patients – those with a large thrombus burden presenting with ST wave elevation myocardial infarction.
The study group receives excimer laser treatment plus direct stenting. The control group receives balloon angioplasty and stenting. The primary endpoint is a combination of ST resolution, which is resolution of the electrocardiogram ST wave elevation injury pattern and the amount of distal embolization as measured by myocardial blush scores.
John Schulte, president and CEO of Spectranetics, said: “The Taami trial represents an important new opportunity for Spectranetics to evaluate the performance of the excimer laser in these acute myocardial infarction patients.”