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NCT number NCT03301246
Study type Interventional
Source Eminence Clinical Research, Inc.
Contact Pam DiCamillo, LVN, CRCC
Phone 903-352-2714
Email PDiCamillo@ECR-Inc.com
Status Not yet recruiting
Phase N/A
Start date November 20, 2017
Completion date May 20, 2018

Clinical Trial Summary

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.


Clinical Trial Description

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.


Study Design


Related Conditions & MeSH terms


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