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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 procedural success of the Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03763747
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 January 30, 2019
Completion date January 30, 2020

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