Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

Wuhan Asia Heart Hospital

Status: Unknown

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

Treatments: Other: Angiography-guided strategy; Other: AccuFFRangio-guided strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05202041

AFCA20211130

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

AccuFFRangio Group

Experimental group

Description:

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.

Treatment:

Other: AccuFFRangio-guided strategy

Angiography Group

Active Comparator group

Description:

The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis \> 70% based on angiographic results.

Treatment:

Other: Angiography-guided strategy