The FAVOR II China Study

Coronary Artery Disease Clinical Trial

Official title:

Functional Diagnostic Accuracy of Quantitative Flow Ratio in On-line Assessment of Coronary Stenosis (The FAVOR II China Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191708
• Other study ID #: FAVOR II -1608
• Status: Completed
• Phase: N/A
• First received: June 16, 2017
• Last updated: July 25, 2017
• Start date: June 13, 2017
• Est. completion date: July 20, 2017

Study information

• Verified date: July 2017
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography. Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperemia).

The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperemia limits more widespread adoption.

QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections. The FAVOR Pilot study (Tu et al.) showed promising results for core laboratory QFR analysis in selected patients. However, the accuracy of QFR when assessed online in the catheterization laboratory is unknown. 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. It is a prospective and multi-center trial with a total of 308 patients conducted at 5 Chinese centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

General Criteria:

• Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI

• Age > 18 years

• Able to provide signed informed consent

Angiographic inclusion criteria:

• At least one stenosis with diameter stenosis of 30%-90% by visual estimate

• Reference vessel size > 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

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

Angiographic exclusion criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Fractional Flow Reserve (FFR)
FFR measured by pressure wire, QFR computed by coronary angiographic images

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	Fuwai Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing
China	Guangdong General Hospital	Guangzhou
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Pulse Medical Imaging Technology (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (1)

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 JH, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Sensitivity: Proportion of patients with positive QFR of FFR positive patients (true positives) compared to proportion of patients with positive percentual diameter stenosis (DS%) assessed by 2D QCA of FFR positive patients (true positives).; Specificity: Proportion of patients with negative QFR of FFR negative patients (true negatives) compared to proportion of patients with negative DS% assessed by 2D QCA of FFR negative patients (true negatives).	1 hour
Secondary	The numerical difference between online QFR and core lab QFR.		1 hour
Secondary	The numerical difference between online QFR and FFR.		1 hour
Secondary	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	Presence of hemodynamically-significant coronary artery stenosis : FFR <= 0.80.	1 hour
Secondary	Feasibility of online computation of QFR	Percentage of successful QFR in all vessels sent to QFR computation	1 hour