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NCT05209503 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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