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Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

NCT ID: NCT03770520

Last Updated: 2018-12-11

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

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-08-30

Brief Summary

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Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.

Detailed Description

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CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.

Conditions

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Coronary Artery Disease Ischemic Heart Disease

Keywords

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Quantitative Flow Ratio Coronary Artery Bypass Grafting Graft patency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.

Study Groups

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QFR-guided

This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR.

Group Type EXPERIMENTAL

QFR-guided CABG

Intervention Type PROCEDURE

CABG surgery based on CAG and QFR

Angio-guided

This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.

Group Type ACTIVE_COMPARATOR

Angio-guided CABG

Intervention Type PROCEDURE

CABG surgery based on heart team discussion of CAG

Interventions

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QFR-guided CABG

CABG surgery based on CAG and QFR

Intervention Type PROCEDURE

Angio-guided CABG

CABG surgery based on heart team discussion of CAG

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with evidence of angina pectoris
* left main or three vessels disease, have the indication for CABG after discussion of the heart team
* at least one main vessels stenosis on 40%-70%

Exclusion Criteria

* former cardiac surgery patients
* need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
* emergent CABG
* acute myocardial infarction time less than 7 days
* life expectancy less than 3 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Ran

Direcotr,chief of ward No.11, Department of cardiac surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ran Dong, MD

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Zhao, MD

Role: CONTACT

Phone: 13810050821

Email: [email protected]

Facility Contacts

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Yang Zhao, MD

Role: primary

Other Identifiers

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Z171100001017059

Identifier Type: -

Identifier Source: org_study_id