Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

Sponsor

Wuhan Asia Heart Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05202041

Collaborator

(none)

500

Enrollment

Arms

13.4

Anticipated Duration (Months)

Study Details

Study Description

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 purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.

Condition or Disease	Intervention/Treatment	Phase
Non ST Segment Elevation Acute Coronary Syndrome Coronary Artery Disease Percutaneous Coronary Intervention	Other: AccuFFRangio-guided strategy Other: Angiography-guided strategy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients

Anticipated Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Feb 14, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AccuFFRangio Group 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.	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.
Active Comparator: Angiography Group The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results.	Other: 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.

Arm

Intervention/Treatment

Experimental: AccuFFRangio Group

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.

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.

Active Comparator: Angiography Group

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

Other: 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.

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Cost analysis [1 year]
Cost savings of AccuFFRangio-guided strategy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wuhan Asia Heart Hospital

Investigators

Study Chair: Dan Song, MD, Wuhan Aisa Heart Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wuhan Asia Heart Hospital

ClinicalTrials.gov Identifier:

NCT05202041

Other Study ID Numbers:

AFCA20211130

First Posted:

Jan 21, 2022

Last Update Posted:

Feb 9, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Acute Coronary Syndrome

Study Results

No Results Posted as of Feb 9, 2022