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Clinical Trial Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06358508
Study type Interventional
Source OrbusNeich
Contact Debbie Morrell, MSME
Phone 954-343-6467
Email dmorrell@orbusneich.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date July 2025

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