Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study

NCT06039748 | Completed

• 1 other identifier: The FAIR Study
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 5

Brief Summary

Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and virtual hyperemic flow derived from contrast frame count without drug-induced hyperemia. The goal of this prospective, multicenter trial is to compare the diagnostic performance of AngioQFA with invasive FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies of the computational fluid dynamics (CFD)-based index of microcirculatory resistance (IMR) using wire-based IMR as the reference standard.

Conditions

Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Coronary Stenosis; Vascular Diseases; Ischemia

Outcome Measures

Primary Outcomes (4)

• Diagnostic sensitivity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.

  Positive FFR is defined as FFR≤0.80. Positive AngioQFA is defined as AngioQFA≤0.80.

  1 hour

• Diagnostic sensitivity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.

  Positive IMR is defined as IMR≥25. Positive AngioIMR is defined as AngioIMR≥25.

  1 hour

• Diagnostic specificity of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.

  Negative FFR is defined as FFR\>0.80. Negative AngioQFA is defined as AngioQFA\>0.80.

  1 hour

• Diagnostic specificity of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.

  Negative IMR is defined as IMR\<25. Negative AngioIMR is defined as AngioIMR\<25.

  1 hour

Secondary Outcomes (11)

• Diagnostic accuracy, positive predictive value and negative predictive value of AngioQFA versus wire-based FFR for demonstration of coronary ischemia on a per-patient basis.

  1 hour

• Diagnostic performance of AngioQFA in comparison to FFR on a per-vessel basis.

  1 hour

• AUC and ROC of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.

  1 hour

• The consistency of AngioQFA Versus wire-based FFR for demonstration of ischemia on a per-vessel basis and a per-patient basis.

  1 hour

• Diagnostic accuracy, positive predictive value and negative predictive value of AngioIMR versus wire-based IMR for demonstration of coronary microvascular dysfunction on a per-patient basis.

  1 hour

Study Arms (1)

AngioQFA

Other: AngioQFA

Interventions

AngioQFA OTHER

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

AngioQFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥18 years.
• Coronary angiography is required for patients with suspected or confirmed coronary artery disease.
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• Diameter stenosis of 30%-90% by visual estimate
• Reference vessel size ≥2 mm in stenotic segment by visual estimate

You may not qualify if:

• Patients meeting any of the following criteria will be excluded:
• Subject has undergone CABG of the target vessel.
• Evidence of an acute myocardial infarction within one week prior to the intended procedure.
• Severe heart failure (NYHA≥III)
• Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
• Serum creatinine level of \>150µmol / L.
• Subject has known allergy to iodinated contrast agents, adenosine, or ATP.
• Pregnant or breastfeeding.
• Repeated enrollment.
• Myocardial bridge or coronary artery fistula on the study lesions.
• The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA.
• Low-quality angiography with poor contrast agent filling or inability to detect vascular boundaries due to various reasons, vascular overlap or severe distortion of the target vessel to fully expose the lesion location is not expected to be calculated.

Sponsors & Collaborators

• Shenzhen Raysight Intelligent Medical Technology Co., Ltd.: lead
• Renmin Hospital of Wuhan University: collaborator
• Yan'an Affiliated Hospital of Kunming Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Jieyang People's Hospital: collaborator
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator

Study Sites (5)

Jieyang People's Hospital

Jieyang, Guangdong, China

Location

The Eighth Affiliated Hospital of Sun Yat-Sen University

Shenzhen, Guangdong, 518033, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430090, China

Location

Yan'an Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650051, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310013, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Coronary Stenosis; Vascular Diseases; Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Jiang

  Renmin Hospital of Wuhan University

  STUDY DIRECTOR

• Qiang Xue

  Yan'an Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Guosheng Fu

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Jianwen Liang

  The Eighth Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Qiang Wu

  Jieyang People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: September 13, 2023
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-04

Locations

CN (5)