Prognostic Implications of AccuFFRangio-guided PCI in STEMI

Coronary Artery Disease Clinical Trial

Official title:

Prognostic Implications of AccuFFRangio-based Functional Evaluation for Guiding Coronary Intervention for Non-IRA Stenosis in Patients With STEMI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05209503
• Other study ID #: AFCA20220105
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2022
• Source: Wuhan Asia Heart Hospital
• Contact: Dan Song, MD
• Phone: +86-027-65796888
• Email: songdan8300[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel-oriented composite endpoints (VOCEs)	Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.	1 year
Primary	Post-PCI AccuFFRangio	AccuFFRangio limits to yield no VOCEs (Composite of vessel-related cardiovascular death, vessel-related myocardial).	1 year
Secondary	Cost analysis	Cost savings of AccuFFRangio-guided strategy. Evaluation of costs by excess/reduced need for PCI when AccuFFRangio and Angiography disagree.	1 year
Secondary	Prognostic implications	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.	1 year