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Clinical Trial Summary

The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using:

- A composite of MACE at 30-day and one (1) year post procedure, and

- Procedural and lesion success


Clinical Trial Description

This prospective, non-randomized, multi-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. This study may treat up to approximately 500 subjects at up to 50 active sites in the U.S. Subjects may be followed up to three (3) years. Subjects will be stratified into one (1) of three (3) arms based on the degree of calcification in the coronary lesion as defined by this protocol. The duration of the study is expected to be approximately four (4) years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01930214
Study type Observational
Source Cardiovascular Systems Inc
Contact
Status Completed
Phase N/A
Start date September 26, 2013
Completion date June 30, 2017

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