Back to results

Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease (FAVOR4-QVAS)

Primary Purpose

Primary Valvular Heart Disease With Comorbid Coronary Artery Disease, Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

QFR-guided strategy

CAG-guided strategy

About this trial

This is an interventional treatment trial for Primary Valvular Heart Disease With Comorbid Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

Voluntarily participate in the trial and provide the informed consent form;
Male or female patients aged ≥ 18 years;
Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.);
At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of ≥ 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization.

Exclusion Criteria:

History of heart surgery;
Planned second-stage PCI or CABG revascularization;
Secondary valvular heart disease (ischemia, cardiomyopathy);
Planned valve intervention surgery through the catheter;
Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician;
QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery);
The target coronary arteries were evaluated to be not suitable for CABG by study physician;
Life expectancy < 3 years.

Sites / Locations

The First Affiliated Hospital of Anhui Medical UniversityRecruiting
Fujian Medical University Union HospitalRecruiting
Fuwai Central China Cardiovascular HospitalRecruiting
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
The Second XiangYa Hospital of Central South UniversityRecruiting
Qilu Hospital of Shandong UniversityRecruiting
The Affiliated Hospital of Qingdao UniversityRecruiting
Ruijin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
Changhai Hospital of ShanghaiRecruiting
Shanghai Chest HospitalRecruiting
Tianjin Chest HospitalRecruiting
The First Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QFR group

CAG group

Arm Description

Outcomes

Primary Outcome Measures

The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis

Secondary Outcome Measures

The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year

The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure

The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)

The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year

The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)

Health-related quality of life

the variables are the EQ-5D scores

Cost effectiveness

the variables are the cost increased for each composite outcome reduction at 30 days after surgery and cost increased for each additional QALY at 1 year and 3 years after surgery

Full Information

NCT ID

NCT03977129

First Posted

June 5, 2019

Last Updated

July 18, 2023

Sponsor

Ruijin Hospital

Collaborators

Med-X Research Institute, Shanghai Jiao Tong University

1. Study Identification

Unique Protocol Identification Number

NCT03977129

Brief Title

Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease

Acronym

FAVOR4-QVAS

Official Title

A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 4, 2019 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Med-X Research Institute, Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the incidence of composite outcome (MACE-5, including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the MACE-5 within 30 days after surgery, as compared with the CAG-guided strategy.

Detailed Description

It is planned to enroll 792 subjects aged ≥18 years, with no gender restriction, who plan to undergo elective open-heart valvular surgery due to primary valvular heart disease, with comorbid coronary artery lesions defined as diameter stenosis of ≥ 50% (visual estimation) that are diagnosed by CAG before the surgery. QFR group: Calculate the QFR values of all target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out. CAG group (control group): All target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization will undergo simultaneous CABG revascularization. Intervention duration: The assessments will be performed after randomization and before the surgery to guide the surgery. No planned interim analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Valvular Heart Disease With Comorbid Coronary Artery Disease, Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

792 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

QFR group

Arm Type

Experimental

Arm Title

CAG group

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

QFR-guided strategy

Intervention Description

In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.

Intervention Type

Other

Intervention Name(s)

CAG-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 ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.

Primary Outcome Measure Information:

Title

The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis

Time Frame

within 30 days after surgery

Secondary Outcome Measure Information:

Title

The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year

Description

Time Frame

within 1 year after surgery

Title

The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)

Time Frame

at 1 year after surgery

Title

The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year

Description

Time Frame

within 3 years after surgery

Title

The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)

Time Frame

at 3 years after surgery

Title

Health-related quality of life

Description

the variables are the EQ-5D scores

Time Frame

within 30 days, 1 year and 3 years after surgery

Title

Cost effectiveness

Description

the variables are the cost increased for each composite outcome reduction at 30 days after surgery and cost increased for each additional QALY at 1 year and 3 years after surgery

Time Frame

within 30 days, 1 year and 3 years after surgery

Other Pre-specified Outcome Measures:

Title

The number of grafts per person

Description

counted as distal anastomosis

Time Frame

at Day 0

Title

The total circulatory time during the surgery

Description

minutes

Time Frame

at Day 0

Title

The total cross-clamp time during the surgery

Description

minutes

Time Frame

at Day 0

Title

The total units of erythrocyte transfusion during and after the surgery till discharge

Time Frame

from Day 0 to discharge day

Title

The number of days from surgery day to discharge day

Time Frame

from Day 0 to discharge day

Title

Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4)

Time Frame

at 1 year after surgery

Title

Change from baseline in the CCS anginal status score (0-4)

Time Frame

at 3 years after surgery

Title

Change from baseline in the New York Heart Association (NYHA) score (1-4)

Time Frame

at 1 year after surgery

Title

Change from baseline in the NYHA score (1-4)

Time Frame

at 3 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Voluntarily participate in the trial and provide the informed consent form; Male or female patients aged ≥ 18 years; Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.); At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of ≥ 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization. Exclusion Criteria: History of heart surgery; Planned second-stage PCI or CABG revascularization; Secondary valvular heart disease (ischemia, cardiomyopathy); Planned valve intervention surgery through the catheter; Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician; QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery); The target coronary arteries were evaluated to be not suitable for CABG by study physician; Life expectancy < 3 years.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunpeng Zhu, MD.

Phone

+8613816819346

Zyp12220@rjh.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Zhao, MD.

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shengxian Tu, PhD.

Organizational Affiliation

Med-X Research Institute, Shanghai Jiao Tong University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yunpeng Zhu, MD.

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Director

Facility Information:

Facility Name

The First Affiliated Hospital of Anhui Medical University

City

Hefei

State/Province

Anhui

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chengxin Zhang, MD

zhangchengxin@ahmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Shenglin Ge, MD

First Name & Middle Initial & Last Name & Degree

Chengxin Zhang, MD

Facility Name

Fujian Medical University Union Hospital

City

Fuzhou

State/Province

Fujian

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Xiao, MD.

xiaojun@fjmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Liangwan Chen, MD

First Name & Middle Initial & Last Name & Degree

Xiaofu Dai, MD

First Name & Middle Initial & Last Name & Degree

Jun Xiao, MD

Facility Name

Fuwai Central China Cardiovascular Hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junlong Hu, MD.

dr_hu@henu.edu.cn

First Name & Middle Initial & Last Name & Degree

Zhaoyun Cheng, MD.

First Name & Middle Initial & Last Name & Degree

Junlong Hu, MD.

Facility Name

The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Zhang, MD

First Name & Middle Initial & Last Name & Degree

Chenhui Qiao, MD

First Name & Middle Initial & Last Name & Degree

Jian Zhang, MD

Facility Name

The Second XiangYa Hospital of Central South University

City

Changsha

State/Province

Hunan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan Zhao, MD.

drzhaoyuan@163.com

First Name & Middle Initial & Last Name & Degree

Xinmin Zhou, MD.

First Name & Middle Initial & Last Name & Degree

Yuan Zhao, MD.

First Name & Middle Initial & Last Name & Degree

Kang Zhou, MD.

Facility Name

Qilu Hospital of Shandong University

City

Jinan

State/Province

Shandong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guangqing Cao, MD

First Name & Middle Initial & Last Name & Degree

Xiquan Zhang, MD

First Name & Middle Initial & Last Name & Degree

Guangqing Cao, MD

Facility Name

The Affiliated Hospital of Qingdao University

City

Qingdao

State/Province

Shandong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenlong Yan, MD

First Name & Middle Initial & Last Name & Degree

Suming Yang, MD

First Name & Middle Initial & Last Name & Degree

Wenlong Yan, MD

Facility Name

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunpeng Zhu, MD.

Phone

+8613816819346

Zyp12220@rjh.com.cn

First Name & Middle Initial & Last Name & Degree

Qiang Zhao, MD.

First Name & Middle Initial & Last Name & Degree

Yunpeng Zhu, MD.

First Name & Middle Initial & Last Name & Degree

Jiaxi Zhu, MD.

First Name & Middle Initial & Last Name & Degree

Yiwei Xu, MD.

Facility Name

Changhai Hospital of Shanghai

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qing Xue, MD.

xq9911310@163.com

First Name & Middle Initial & Last Name & Degree

Zhiyun Xu, MD.

First Name & Middle Initial & Last Name & Degree

Lin Han, MD.

First Name & Middle Initial & Last Name & Degree

Qing Xue, MD.

Facility Name

Shanghai Chest Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Busheng Zhang, MD.

albmu@sina.cn

First Name & Middle Initial & Last Name & Degree

Dan Zhu, MD.

First Name & Middle Initial & Last Name & Degree

Busheng Zhang, MD.

Facility Name

Tianjin Chest Hospital

City

Tianjin

State/Province

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunpeng Bai, MD

oliverwhite@126.com

First Name & Middle Initial & Last Name & Degree

Zhigang Guo, MD

First Name & Middle Initial & Last Name & Degree

Nan Jiang, MD

First Name & Middle Initial & Last Name & Degree

Qinliang Chen, MD

Facility Name

The First Affiliated Hospital Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Teng

tengpeng@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Liang Ma, MD

First Name & Middle Initial & Last Name & Degree

Peng Teng, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease

We'll reach out to this number within 24 hrs