NCT03405506

Brief Summary

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance of coronary stenosis as if the stenosis was revascularized. The purpose of this study is to evaluate the diagnostic accuracy of QFR in in tandem lesions with fractional flow reserve (FFR) as the reference standard. The secondary purpose is to evaluate the diagnostic accuracy of QFR-based virtual stent technique in predicting the FFR values after revascularizing the culprit lesion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

January 12, 2018

Last Update Submit

May 28, 2025

Conditions

Coronary Artery DiseaseCardiovascular DiseasesMyocardial IschemiaArterial Occlusive DiseasesHeart DiseasesVascular DiseasesArteriosclerosis

Keywords

Fractional Flow ReserveQuantitative Coronary AngiographyCoronary artery diseaseQuantitative Flow RatioTandem lesionVirtual stenting

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention

    Diagnostic accuracy was defined as the concordance ratio of QFR evaluated outcomes (≤ 0.8 or \> 0.8) with the reference standard FFR evaluated outcomes (≤ 0.8 or \> 0.8)

    1 hour

Secondary Outcomes (1)

  • Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion

    1 hour

Interventions

Quantitative Flow Ratio (QFR)DEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis

You may qualify if:

  • Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI;
  • Age \> 18 years;
  • Able to provide signed informed consent.
  • At least two localized lesions on the same coronary artery;
  • More than 50% diameter stenosis (DS) estimated by QCA on each lesion;
  • At least 10 mm relatively normal lumen (at most 20% DS) between two lesions;
  • Reference vessel size \> 2 mm in stenotic segment by visual estimate.

You may not qualify if:

  • 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;
  • Serious complications:
  • Evidence of cardiac rupture;
  • History of bleeding (intracranial hemorrhage, gastrointestinal bleeding, etc.);
  • Acute or chronic blood system diseases, including hemoglobin \< 10 g / L, or platelet count \< 50 × 109 / L;
  • Accompanied by other diseases might inducing life expectancy shorter than several months;
  • History of severe renal insufficiency and hypohepatia (liver failure, cirrhosis, portal hypertension and active hepatitis)
  • Aneurysm, arterial / venous malformation, aortic dissection;
  • Cardiogenic shock or circulation capacity failure;
  • Two-degree and more severe atrioventricular block, with no permanent pacemaker implanted;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huadong Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related 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 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: 27712739BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular DiseasesMyocardial IschemiaArterial Occlusive DiseasesHeart DiseasesVascular DiseasesArteriosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

June 13, 2017

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)