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Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

Primary Purpose

Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AccuFFRangio-guided strategy
Angiography-guided strategy
Sponsored by
Wuhan Asia Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non ST Segment Elevation Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AccuFFRangio Group

    Angiography Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Cost analysis
    Cost savings of AccuFFRangio-guided strategy.

    Full Information

    First Posted
    January 7, 2022
    Last Updated
    February 8, 2022
    Sponsor
    Wuhan Asia Heart Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05202041
    Brief Title
    Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS
    Official Title
    Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2022 (Anticipated)
    Primary Completion Date
    February 14, 2023 (Anticipated)
    Study Completion Date
    March 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wuhan Asia Heart Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non ST Segment Elevation Acute Coronary Syndrome, Coronary Artery Disease, Percutaneous Coronary Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AccuFFRangio Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Angiography Group
    Arm Type
    Active Comparator
    Arm Description
    The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results.
    Intervention Type
    Other
    Intervention Name(s)
    AccuFFRangio-guided strategy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Angiography-guided strategy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vessel-oriented composite endpoints (VOCEs)
    Description
    Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
    Time Frame
    1 year
    Title
    Post-PCI AccuFFRangio
    Description
    AccuFFRangio limits to yield no VOCEs.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Cost analysis
    Description
    Cost savings of AccuFFRangio-guided strategy.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Song, MD
    Phone
    +86-027-65796888
    Email
    songdan8300@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Song, MD
    Organizational Affiliation
    Wuhan Aisa Heart Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

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