Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

Coronary Artery Disease Clinical Trial

— DeFACTO  

Official title:

Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233518
• Other study ID #: CP-901-001
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2020
• Source: HeartFlow, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

Description:

285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Patients providing written informed consent

• Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)

• Has undergone >64 multidetector row CCTA within 60 days prior to ICA

• No cardiac interventional therapy between the CCTA and ICA

Exclusion Criteria:

• Prior coronary artery bypass graft (CABG) surgery

• Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel

• Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD

• Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)

• Recent prior myocardial infarction within 40 days of ICA

• Known complex congenital heart disease

• Prior pacemaker or internal defibrillator lead implantation

• Prosthetic heart valve

• Significant arrhythmia or tachycardia

• Impaired chronic renal function (serum creatinine >1.5 mg/dl

• Patients with known anaphylactic allergy to iodinated contrast

• Pregnancy or unknown pregnancy status

• Body mass index >35

• Patient requires an emergent procedure

• Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema

• Any active, serious, life-threatening disease with a life expectancy of less than 2 months

• Inability to comply with study procedures

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• FFR
Fractional flow reserve measured during cardiac catheterization

Locations

Country	Name	City	State
United States	Spring Hill Hospital	Mobile	Alabama

Sponsors (4)

Lead Sponsor	Collaborator
HeartFlow, Inc.	Baim Institute for Clinical Research, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7. — View Citation

Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reser — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone	Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values =0.80 considered diseased; values >0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses =50% considered obstructive and <50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.	1 day
Secondary	Diagnostic Performance of CCTA Plus FFRCT at the Subject Level	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.	1 day