The FAVOR II China Study

NCT03191708 | Completed

• 1 other identifier: FAVOR II -1608
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 5

Brief Summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases; Heart Diseases; Vascular Diseases

Keywords

Fractional Flow Reserve; Quantitative Coronary Angiography; Coronary artery disease; Angina pectoris; Quantitative Flow Ratio

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.

  Presence of hemodynamically-significant coronary artery stenosis : FFR \<= 0.80.

  1 hour

Secondary Outcomes (5)

• In comparison to online 2D QCA, sensitivity and specificity of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard

  1 hour

• The numerical difference between online QFR and core lab QFR.

  1 hour

• The numerical difference between online QFR and FFR.

  1 hour

• The area under the receiver operating characteristic curve of online QFR in determining presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard

  1 hour

• Feasibility of online computation of QFR

  1 hour

Interventions

Fractional Flow Reserve (FFR) DIAGNOSTIC_TEST

FFR measured by pressure wire, QFR computed by coronary angiographic images

Also known as: Quantitative Flow Ratio (QFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease admitted for coronary angiography due to high risk of significant coronary stenosis

You may qualify if:

• General Criteria:
• Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
• Age \> 18 years
• Able to provide signed informed consent
• At least one stenosis with diameter stenosis of 30%-90% by visual estimate
• Reference vessel size \> 2 mm in stenotic segment by visual estimate

You may not qualify if:

• General Criteria:
• Ineligible for diagnostic intervention or FFR examination
• Myocardial infarction within 72 hours
• Severe heart failure (NYHA≥III)
• S-creatinine\>150µmol/L or GFR\<45 ml/kg/1.73m2
• Allergy to contrast agent or adenosine
• Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation
• The interrogated stenosis is caused by myocardial bridge
• Ostial lesions less than 3 mm to the aorta
• Side branches of the bifurcation lesions with Median Classification of 111 or 101
• Poor angiographic image quality precluding contour detection
• Severe overlap of stenotic segments
• Severe tortuosity of target vessel

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Pulse Medical Imaging Technology (Shanghai) Co., Ltd: collaborator

Study Sites (5)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Guangdong General Hospital

Guangzhou, China

Location

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, China

Location

Related Publications (2)

• Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

  PMID: 27712739 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases; Heart Diseases; Vascular Diseases; Angina Pectoris

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 19, 2017
• Study Start: June 13, 2017
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CN (5)