Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting (FORTRESS)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Arteriosclerosis; Arterial Occlusive Diseases
• Intervention / Treatment: Device: Quantitative Flow Ratio (QFR)

Detailed Description

QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel. 3D coronary models can be reconstructed based on two angiographic projections to obtain the geometric parameters, including vascular diameter or cross-sectional area. According to the lesion stenosis, vessel curvature, conical geometry and reference lumen characteristics, pressure drop can be calculated in real time based on its relationship with blood flow. There is no need for pressure wire and adenosine / ATP induced maximum hyperemia compared with FFR.

The FAVOR Pilot Study and FAVOR II China Study showed promising results for diagnostic accuracy in consecutive patients. However, the diagnostic accuracy of QFR in specific tandem lesions needs further investigation. Furthermore, using the virtual stent technology to accurately assess the culprit lesion and choose the optimal treatment is significant in precisely guiding PCI surgery.

• Study Type: Observational
• Enrollment (Actual): 308

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huadong Hospital affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• General inclusion Criteria:

  1. Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI;
  2. Age > 18 years;
  3. Able to provide signed informed consent.

• Angiographic inclusion criteria:

  1. At least two localized lesions on the same coronary artery;
  2. More than 50% diameter stenosis (DS) estimated by QCA on each lesion;
  3. At least 10 mm relatively normal lumen (at most 20% DS) between two lesions;
  4. Reference vessel size > 2 mm in stenotic segment by visual estimate.

Exclusion Criteria:

• General exclusion criteria:

  1. Ineligible for diagnostic intervention or FFR examination;
  2. Myocardial infarction within 72 hours;
  3. Severe heart failure (NYHA≥III);
  4. S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2;
  5. Allergy to contrast agent or adenosine;
  6. Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation;

  7. Serious complications:

     1. Evidence of cardiac rupture;
     2. History of bleeding (intracranial hemorrhage, gastrointestinal bleeding, etc.);
     3. Acute or chronic blood system diseases, including hemoglobin < 10 g / L, or platelet count < 50 × 109 / L;
     4. Accompanied by other diseases might inducing life expectancy shorter than several months;
     5. History of severe renal insufficiency and hypohepatia (liver failure, cirrhosis, portal hypertension and active hepatitis)
     6. Aneurysm, arterial / venous malformation, aortic dissection;
  8. Cardiogenic shock or circulation capacity failure;
  9. Two-degree and more severe atrioventricular block, with no permanent pacemaker implanted;
  10. Pregnancy or lactation;
  11. The investigators believe that the treatment regimen may be detrimental to the patient or the enrollment of this subject may affect the specific assessment of the trial;

• Angiographic exclusion criteria:

  1. The interrogated stenosis is caused by myocardial bridge;
  2. Ostial lesions less than 3 mm to the aorta;
  3. Side branches of the bifurcation lesions with Median Classification of 111 or 101;
  4. Severe overlap or shorten of stenosis segment;
  5. Severe tortuosity of target vessel;
  6. Poor angiographic image quality precluding contour detection.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion	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

Collaborators and Investigators

• Sponsor: Pulse Medical Imaging Technology (Shanghai) Co., Ltd
• Collaborators: Shanghai Chest Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2017
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery disease; Fractional Flow Reserve; Quantitative Coronary Angiography; Quantitative Flow Ratio; Tandem lesion; Virtual stenting
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Vascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: CARDIAC201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No