Status:
COMPLETED
An Observational Study of Cholesterol in Coronary Arteries
Lead Sponsor:
Infraredx
Conditions:
Myocardial Infarction
Angina
Eligibility:
All Genders
18+ years
Brief Summary
In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cho...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age.
- Subject is scheduled for elective coronary catheterization.
- LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.
- At least one chemogram from a native coronary artery is available for submission to the registry.
- Able to read, understand and sign the informed consent.
Exclusion
- Subject is pregnant or nursing.
- Subject life expectancy is less than 2 years at time of index catheterization.
- All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.
- Unable to give informed consent
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
2067 Patients enrolled
Trial Details
Trial ID
NCT00831116
Start Date
February 1 2009
End Date
April 1 2017
Last Update
June 9 2017
Active Locations (22)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
4
University of California Irvine Medical Center
Orange, California, United States, 92868