Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.

Completed

Conditions studied: Atherosclerosis, Coronary

In brief

Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions. Currently, FFR-CT algorithms can only be optimized using theoretical models and can only be validated in large multi-center clinical trials. Using patient specific 3D printed coronary phantoms would allow optimization of FFR-CT algorithms with a measured validation technique without the need for large clinical trials. Thus the investigators believe that this study will result in a FFR-CT algorithm/method with a better predictability for arterial lesion severity than those existing on the market today. Flow measurements will be compared with: CT-FFR for both patients and phantoms, angio lab FFR measurements and 30 days follow-up. This pilot clinical study includes \~50 patients over a year and half at GVI.

Key facts

Study ID

NCT03149042

Run by

State University of New York at Buffalo

People needed

75

Starts

2016-05-28

Expected to finish

2019-04-21

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All the patients >18 yrs of age , who are undergoing CCTA and angio-FFR. Patients who are (1) scheduled for clinically mandated elective invasive coronary angiography (ICA) at Buffalo General Hospital or (2) clinically mandated CTA will be screened.

You may not qualify if…

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• atrial fibrillation,
• Renal insufficiency (estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2),
• Active Bronchospasm prohibiting the use of beta blockers
• Morbid obesity (body mass index 40 kg/m2)
• Contraindications to iodinated contrast.
• Emergencies requiring immediate intervention or patients unable to consent.
• Patients not showing coronary calcium during Calcium Scoring procedures

Where it is running

• Clinical and Translational Research Center Room 8052 — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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