Coronary Artery Disease Clinical Trial
Official title:
Artimes Pro Low Profile 1.00mm and 1.25mm Dilatation Catheters for Pre-Dilatation of Stenosis and Occlusion in Patients With Symptomatic Ischemic Heart Disease
This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this investigational device study.
Patients who require initial pre-dilatation using the study device, and then undergo
definitive therapy using additional PTCA catheters and stents, according to standard of care
will be enrolled in this study.
A maximum of 60 subjects with native coronary artery lesions or occlusions will be treated
using the Artimes pro Balloon Dilatation Catheters in a 3:1 ratio using the 1.0mm and 1.25mm
dilatation catheters for pre-dilatation and will complete the study within the U.S. This
equals 45 patients treated using the 1.0mm dilatation catheter, and 15 patients treated with
the 1.25mm dilatation catheter for a total of 60 subjects enrolled and treated.
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