Prognostic Implications of AccuFFRangio-guided PCI in STEMI

Not Applicable

• Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction
• Interventions: Other: AccuFFRangio-guided strategy; Other: Angiography-guided strategy

• Registration Number: NCT05209503
• Lead Sponsor: Wuhan Asia Heart Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-01-26
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09
• Study Start: 2022-02-15
• Primary Completion: 2023-02-28
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cost analysis	1 year	Cost savings of AccuFFRangio-guided strategy. Evaluation of costs by excess/reduced need for PCI when AccuFFRangio and Angiography disagree.
Prognostic implications	1 year	The time from randomization to first occurrence of any of composite outcome including vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.