NCT05202041

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

January 7, 2022

Last Update Submit

February 8, 2022

Conditions

Non ST Segment Elevation Acute Coronary SyndromeCoronary Artery DiseasePercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

  • Vessel-oriented composite endpoints (VOCEs)

    Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.

    1 year

  • Post-PCI AccuFFRangio

    AccuFFRangio limits to yield no VOCEs.

    1 year

Secondary Outcomes (1)

  • Cost analysis

    1 year

Study Arms (2)

AccuFFRangio Group

EXPERIMENTAL

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

Angiography Group

ACTIVE COMPARATOR

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

Other: Angiography-guided strategy

Interventions

AccuFFRangio-guided strategyOTHER

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.

AccuFFRangio Group
Angiography-guided strategyOTHER

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.

Angiography Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • LVEF ≤ 40%
  • eGFR \< 60 mL/min
  • Allergy to contrast media, adenosine
  • Prior CABG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dan Song, MD

    Wuhan Aisa Heart Hospital

    STUDY CHAIR

Central Study Contacts

Dan Song, MD

CONTACT

+86-027-65796888songdan8300@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 21, 2022

Study Start

February 15, 2022

Primary Completion

February 14, 2023

Study Completion

March 30, 2023

Last Updated

February 9, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share