The FAVOR II China Study

• Sponsor: China National Center for Cardiovascular Diseases (Other)
• Overall Status: Completed
• CT.gov ID: NCT03191708
• Collaborator: Pulse Medical Imaging Technology (Shanghai) Co., Ltd (Industry)
• Enrollment: 308
• Locations: 5
• Actual Duration (Months): 1.2
• Patients Per Site: 61.6
• Patients Per Site Per Month: 50.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases; Heart Diseases; Vascular Diseases	Diagnostic Test: Fractional Flow Reserve (FFR)

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 308 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Functional Diagnostic Accuracy of Quantitative Flow Ratio in On-line Assessment of Coronary Stenosis (The FAVOR II China Study)
• Actual Study Start Date: Jun 13, 2017
• Actual Primary Completion Date: Jul 20, 2017
• Actual Study Completion Date: Jul 20, 2017

Outcome Measures

Primary Outcome Measures

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. [1 hour]

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

Secondary Outcome Measures

1. 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]

   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).

2. The numerical difference between online QFR and core lab QFR. [1 hour]

3. The numerical difference between online QFR and FFR. [1 hour]

4. 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]

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

5. Feasibility of online computation of QFR [1 hour]

   Percentage of successful QFR in all vessels sent to QFR computation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China
2	Chinese PLA General Hospital	Beijing		China
3	Peking University Third Hospital	Beijing		China
4	Guangdong General Hospital	Guangzhou		China
5	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai		China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: fuwaihospital, Professor, China National Center for Cardiovascular Diseases
• ClinicalTrials.gov Identifier: NCT03191708
• Other Study ID Numbers: FAVOR II -1608
• First Posted: Jun 19, 2017
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by fuwaihospital, Professor, China National Center for Cardiovascular Diseases: Fractional Flow Reserve; Quantitative Coronary Angiography; Coronary artery disease; Angina pectoris; Quantitative Flow Ratio
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia

Study Results

No Results Posted as of Jul 26, 2017