Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

Study Overview
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Brief Summary
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This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.

Official Title
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Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients

Conditions
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Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Other: AccuFFRangio-guided strategy
* Other: Angiography-guided strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years and older Non-ST-segment elevation acute coronary syndrome patients with at least 1 non-IRA Diameter stenosis of 50%-90% by visual estimate Reference vessel size > 2 mm in stenotic segment by visual estimate Exclusion Criteria: LVEF ≤ 40% eGFR < 60 mL/min Allergy to contrast media, adenosine Prior CABG

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuFFRangio Group<br>NSTE-ACS patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography. First, the revascularization of the criminal vessel (PCI) was completed. The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good. The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8. | Other: AccuFFRangio-guided strategy<br>* In this study, the AccuFFRangio-guided strategy will be applied to in the AccuFFRangio group in which calculation of the AccuFFRangio values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to PCI revascularization will be carried out. If AccuFFRangio ≤ 0.80, then simultaneous PCI revascularization of target blood vessels will be carried out. If AccuFFRangio > 0.80, then no PCI revascularization of target blood vessels will be carried out.<br>|
| Active Comparator: Angiography Group<br>The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results. | Other: Angiography-guided strategy<br>* In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 70% (visual estimation) and suited for PCI revascularization will undergo PCI revascularization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel-oriented composite endpoints (VOCEs) | Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. | 1 year | 
| Post-PCI AccuFFRangio | AccuFFRangio limits to yield no VOCEs. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost analysis | Cost savings of AccuFFRangio-guided strategy. | 1 year |