title: Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCTin Coronary Care (ADVANCE) registry.
abstract: BACKGROUND
  Coronary CT angiography (CTA) is a reliable tool for the detection of coronary artery disease (CAD) that conveys significant prognostic information. It does not provide data on the hemodynamic significance of a given lesion, particularly in intermediate-grade stenosis. Fractional flow reserve by CT (FFRCT) can accurately predict the hemodynamic significance of coronary lesions. The primary objective of this registry is to determine whether the integration of FFRCTas an adjunct to coronary CTA will lead to a significant change in the management of CAD in patients with stable angina.
  
  
  METHODS
  The ADVANCE Registry is a multi-center, prospective registry designed to evaluate utility, clinical outcomes and resource utilization following FFRCT-guided treatment in clinically stable, symptomatic patients diagnosed with CAD by coronary CTA. Approximately 5000 patients will be enrolled from up to 50 sites in Europe, USA, Canada and Asia. Requirement for enrollment is the presence of atherosclerosis on coronary CTA. For each enrolled patient, a clinical management review committee will use data from coronary CTA and FFRCTto determine the management plan using the following criteria: (a) optimal medical therapy, (b) percutaneous coronary intervention, (c) coronary artery bypass graft surgery, or (d) more information required. The primary endpoint of the registry is the reclassification rate between the management plan based on coronary CTA alone versus CTA plus FFRCT. The secondary endpoints of the registry include the evaluation of the rate of invasive coronary angiography (ICA), revascularization, major adverse coronary events, resource utilization, cumulative radiation dose exposure and the rate of ICA without obstructive CAD at 3-year follow-up.
  
  
  CONCLUSIONS
  The ADVANCE registry is designed to assess the real-world impact of FFRCTon the clinical management of stable CAD when used along with coronary CTA.
authors.affiliation: William Beaumont Hospital, Royal Oaks, MI, USA.
authors.forename: Kavitha M
authors.initials: KM
authors.lastname: Chinnaiyan
authors.affiliation: Wakayama Medical University, Wakayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Akasaka
authors.affiliation: Aichi Medical University, Aichi, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Amano
authors.affiliation: Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Jeroen J
authors.initials: JJ
authors.lastname: Bax
authors.affiliation: Department of Radiology, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Philipp
authors.initials: P
authors.lastname: Blanke
authors.affiliation: Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium.
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.affiliation: Shin Koga Hospital, Fukuoka, Japan.
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kawasaki
authors.affiliation: Department of Radiology, University of British Columbia, Vancouver, BC, Canada. Electronic address: jleipsic@providencehealth.bc.ca.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: Gifu Heart Center, Gifu, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Matsuo
authors.affiliation: Iwate Medical University, Iwate, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.affiliation: Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Koen
authors.initials: K
authors.lastname: Nieman
authors.affiliation: Aarhus University Hospital, Aarhus Skejby, Denmark.
authors.forename: Bjarne L
authors.initials: BL
authors.lastname: Norgaard
authors.affiliation: Duke University School of Medicine, Durham, NC, USA.
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.affiliation: Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Pontone
authors.affiliation: Loyola University Medical Center, Maywood, IL, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Rabbat
authors.affiliation: HeartFlow, Redwood City, CA, USA.
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.affiliation: University of Southern Denmark, Odense, Denmark.
authors.forename: Neils Peter
authors.initials: NP
authors.lastname: Sand
authors.affiliation: William Beaumont Hospital, Royal Oaks, MI, USA.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Raff
mesh_terms: D001208:Asia; D002170:Canada; D000072226:Computed Tomography Angiography; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000628:therapy; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000628:therapy; D005060:Europe; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D012720:Severity of Illness Index; D014481:United States
keywords: Coronary artery disease; FFRct; Ischemia; Reclassification