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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-13

Study Completion Date

2024-01-14

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AngioQFA

Intervention Type OTHER

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

Interventions

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AngioQFA

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years.
2. Coronary angiography is required for patients with suspected or confirmed coronary artery disease.
3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

1. Diameter stenosis of 30%-90% by visual estimate
2. Reference vessel size ≥2 mm in stenotic segment by visual estimate

Exclusion Criteria

Patients meeting any of the following criteria will be excluded:

1. Subject has undergone CABG of the target vessel.
2. Evidence of an acute myocardial infarction within one week prior to the intended procedure.
3. Severe heart failure (NYHA≥III)
4. Patients with other serious conditions not eligible for clinical trials, such as severe arrhythmia or tachycardia, sinus syndrome, asthma, severe chronic obstructive pulmonary disease.
5. Serum creatinine level of \>150µmol / L.
6. Subject has known allergy to iodinated contrast agents, adenosine, or ATP.
7. Pregnant or breastfeeding.
8. Repeated enrollment.
9. Any other factors that the researchers consider not suitable for diagnostic intervention or FFR and IMR detection, such as the target vessel has collateral circulation, coronary spasm, the target vessel plaque rupture resulting in myocardial infarction, or other reasons deemed unsuitable for inclusion.

1. Myocardial bridge or coronary artery fistula on the study lesions.
2. The target lesion ≥50% diameter stenosis in the left main coronary artery or ostial lesions less than 3 mm to the RCA.
3. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No