NCT05202041

Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Wuhan Asia Heart Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non ST Segment Elevation Acute Coronary Syndrome
• Coronary Artery Disease
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
OTHER	AccuFFRangio-guided strategy	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.
OTHER	Angiography-guided strategy	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.

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-02-14
• Completion: 2023-03-30
• First posted: 2022-01-21
• Last updated: 2022-02-09