Status:
COMPLETED
Validation of Stenosis Assessment by Coronary Artery Computed Tomography Against Invasive Measurements of Fractional Flow Reserve in Patients With Significant Coronary Artery Stenoses
Lead Sponsor:
Piedmont Healthcare
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness of CorCTA by comparing the results of the test with another imaging method called Fractional Flow Reserve (FFR), which is done as a part of the cardiac cathe...
Detailed Description
Invasive X-ray coronary angiography remains the "reference standard" for the evaluation of coronary artery stenoses. Recently, coronary artery computed tomography angiography (CorCTA) has been introdu...
Eligibility Criteria
Inclusion
- Age 21-85
- Presence of at least one obstructive coronary artery stenosis as defined by:
- Previous catheterization or CT angiogram with any lesion 70% or greater
- Previous positive functional stress test (this does not include CTA alone)
- Ability and Willingness to provide informed consent
- Ability and Willingness to perform required follow up procedures
Exclusion
- History of coronary artery bypass graft surgery
- Previously revascularized lesion
- Creatinine\>1.6 mg/dL or GFR\<30 pre-procedure per institutional standards
- Known Pregnancy
- Inability to perform CTA
- Arrhythmia precluding diagnostic CT examination
- Contrast agent allergy that cannot be adequately premedicated
- Severe PVD precluding cardiac catheterization
- Patient not a candidate for IVUS and FFR
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to perform required follow up procedures
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00817102
Start Date
November 1 2008
End Date
April 1 2013
Last Update
April 15 2014
Active Locations (1)
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1
Piedmont Hospital
Atlanta, Georgia, United States, 30309