Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment ffr (pressurewire)
Phase phase 4
Sponsor Shanghai 10th People's Hospital
Start date December 2012
End date March 2013
Trial size 300 participants
Trial identifier NCT01747317, TENTH1010

Summary

Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Single arm study.The investigators will conduct computed tomography,angiography and FFR measurement during angiography in this single arm.
ffr (pressurewire) PressureWire™ Certus(St. Jude Medical Systems)
Fractional flow reserve measured during cardiac catheterization——A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden;ComboWire, Volcano Corporation, San Diego, California) will be advanced past the stenosis.

Primary Outcomes

Measure
Diagnostic Accuracy of FFRCT
time frame: 1 day

Secondary Outcomes

Measure
Diagnostic accuracy of FFRCT at the subject level
time frame: 1 day
Diagnostic accuracy of FFRCT at the vessel level
time frame: 1 day
FFR Numerical Correlation
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter - Undergoing clinically indicated invasive coronary angiography with FFR Exclusion Criteria: - A history of CABG surgery - Prior percutaneous coronary intervention with suspected instent restenosis - Suspicion of or recent acute coronary syndrome - Complex congenital heart disease - Prior pacemaker or defibrillator - Prosthetic heart valve - Significant arrhythmia - heart rate >100 beats/min - systolic blood pressure≤90 mmHg - contraindication to beta blockers, nitroglycerin or adenosine - Serum creatinine level greater than 1.5 mg per dL - Allergy to iodinated contrast - Pregnant state - Body mass index greater than 35 - Evidence of active clinical instability or lifethreatening disease - Canadian Cardiovascular Society class IV angina - nonevaluable CCTA as determined by the CCTA core laboratory - Inability to adhere to study procedures

Additional Information

Official title Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography
Principal investigator Ya-Wei Xu, MD, FACC
Description Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date. Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent. Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Shanghai 10th People's Hospital.