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Coronary Artery DiseaseNCT03191708

The FAVOR II China Study

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by China National Center for Cardiovascular Diseases at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fractional Flow Reserve (FFR)
How many people
308 participants
Where
5 sitesChina
Study dates
13 Jun 2017to 20 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Fuwai Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Guangdong General Hospital

    Guangzhou

  • Shanghai Chest Hospital, Shanghai Jiao Tong University

    Shanghai

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Fractional Flow Reserve (FFR)
Keywords
Fractional Flow Reserve, Quantitative Coronary Angiography, Coronary artery disease, Angina pectoris, Quantitative Flow Ratio
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Coronary Disease, Arterial Occlusive Diseases, Heart Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractional Flow Reserve (FFR)Diagnostic test

    Also called Quantitative Flow Ratio (QFR)

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 hour

Secondary outcomes (5)

  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

    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).

    Measured: 1 hour

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

    Measured: 1 hour

  3. The numerical difference between online QFR and FFR.

    Measured: 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

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

    Measured: 1 hour

  5. Feasibility of online computation of QFR

    Percentage of successful QFR in all vessels sent to QFR computation

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2017
  2. Study start13 Jun 2017
  3. Primary completion20 Jul 2017
  4. Study completion20 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03191708
Sponsor's protocol ID
FAVOR II -1608
Status last verified
Jul 2017
First submitted
16 Jun 2017
Last updated
26 Jul 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 27712739

  • 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.

    PubMed 29101020

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Ischemia, run by China National Center for Cardiovascular Diseases at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03191708, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.

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