Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon.
The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in diameter.
It will evaluate the 12-month target lesion failure rate, defined as myocardial infarction related to the target vessel, the need for a revascularization procedure or cardiac mortality. The company said at least 480 patients will be enrolled in the study at 40 U.S. sites.
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