Prognostic Implications of AccuFFRangio-guided PCI in STEMI

NCT ID: NCT05209503

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Artery Disease ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AccuFFRangio Group

STEMI 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.

Group Type EXPERIMENTAL

AccuFFRangio-guided strategy

Intervention Type OTHER

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 Group

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

Group Type ACTIVE_COMPARATOR

Angiography-guided strategy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan Song, MD

Role: STUDY_CHAIR

Wuhan Aisa Heart Hospital

Central Contacts

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Dan Song, MD

Role: CONTACT

+86-027-65796888

Other Identifiers

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AFCA20220105

Identifier Type: -

Identifier Source: org_study_id

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