Prognostic Implications of AccuFFRangio-guided PCI in STEMI

Wuhan Asia Heart Hospital

Status: Unknown

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05209503

AFCA20220105

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 aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 Years and older
• STEMI patients with primary percutaneous coronary intervention within 24 hours 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:

STEMI 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