Primary Valvular Heart Disease With Comorbid Coronary Artery DiseaseFAVOR IV-QVASNCT03977129
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease
A study testing QFR-guided strategy and CAG-guided strategy in people with Primary Valvular Heart Disease With Comorbid Coronary Artery Disease and Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease, run by Ruijin Hospital at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- QFR-guided strategy and CAG-guided strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 12 sitesChina
- Study dates
- 4 Aug 2019to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The Second XiangYa Hospital of Central South University
Changsha, Hunan
Fujian Medical University Union Hospital
Fuzhou, Fujian
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Qilu Hospital of Shandong University
Jinan, Shandong
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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
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.
Read the 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.
- Conditions
- 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
- Being tested
- QFR-guided strategy, CAG-guided strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR-guided strategyDevice
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.
CAG-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 ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
| Study group | Role | What they receive |
|---|---|---|
| QFR group | Experimental | Not described Receives: Device: QFR-guided strategy |
| CAG group | Active comparator | Not described Receives: Other: CAG-guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 30 days after surgery
Secondary outcomes (6)
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
Measured: within 1 year after surgery
The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
Measured: at 1 year after surgery
The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 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
Measured: within 3 years after surgery
The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
Measured: at 3 years after surgery
Health-related quality of life
the variables are the EQ-5D scores
Measured: within 30 days, 1 year and 3 years after surgery
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
Measured: within 30 days, 1 year and 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start4 Aug 2019
- Primary completion30 Sep 2024
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Valvular Heart Disease With Comorbid Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Med-X Research Institute, Shanghai Jiao Tong University
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD., Principal investigator, Ruijin HospitalShengxian Tu, PhD., Principal investigator, Med-X Research Institute, Shanghai Jiao Tong UniversityYunpeng Zhu, MD., Study director, Ruijin HospitalMario Gaudino, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977129
- Sponsor's protocol ID
- 2018CR001
- Acronym
- FAVOR IV-QVAS
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2019
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhu Y, Cheng Z, Zhao Y, Han L, Zhang W, Zhang C, Yang S, Ma L, Qiao C, Guo Z, Zhu D, Zhang X, Chen L, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Zhu J, Xu Z, Qin G, Wijns W, Redfors B, Sandner S, Gaudino M, Tu S, Zhao Q. Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial. Lancet. 2026 Mar 21;407(10534):1161-1170. doi: 10.1016/S0140-6736(25)02418-3.
PubMed 41864747Zhu J, Zhu Y, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Kang L, Tu S, Zhao Q. Preliminary outcomes of quantitative flow ratio-guided coronary bypass grafting in primary valve surgery: A propensity score weighted analysis. JTCVS Open. 2024 Jun 25;21:90-108. doi: 10.1016/j.xjon.2024.06.008. eCollection 2024 Oct.
PubMed 39534354
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03977129
- Acronym / sponsor ID
- FAVOR IV-QVAS / 2018CR001
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 792 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Med-X Research Institute, Shanghai Jiao Tong University
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QFR group | Experimental | Device: QFR-guided strategy |
| CAG group | Active comparator | Other: CAG-guided strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QFR-guided strategyIn 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. | Device | QFR group |
| CAG-guided strategyIn 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. | Other | CAG group |
Primary outcome
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
6 secondary outcomes
The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year
Time frame: within 1 year after surgery
The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
Time frame: at 1 year after surgery
The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year
Time frame: within 3 years after surgery
The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
Time frame: at 3 years after surgery
Health-related quality of life
Time frame: within 30 days, 1 year and 3 years after surgery
Cost effectiveness
Time frame: within 30 days, 1 year and 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 41864747Zhu Y, Cheng Z, Zhao Y, Han L, Zhang W, Zhang C, Yang S, Ma L, Qiao C, Guo Z, Zhu D, Zhang X, Chen L, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Zhu J, Xu Z, Qin G, Wijns W, Redfors B, Sandner S, Gaudino M, Tu S, Zhao Q. Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial. Lancet. 2026 Mar 21;407(10534):1161-1170. doi: 10.1016/S0140-6736(25)02418-3.
- Derived from this study: PubMed 39534354Zhu J, Zhu Y, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Kang L, Tu S, Zhao Q. Preliminary outcomes of quantitative flow ratio-guided coronary bypass grafting in primary valve surgery: A propensity score weighted analysis. JTCVS Open. 2024 Jun 25;21:90-108. doi: 10.1016/j.xjon.2024.06.008. eCollection 2024 Oct.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Zhao, MD. principal investigator
Ruijin Hospital
Shengxian Tu, PhD. principal investigator
Med-X Research Institute, Shanghai Jiao Tong University
Yunpeng Zhu, MD. study director
Ruijin Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QFR-guided strategy and CAG-guided strategy in people with Primary Valvular Heart Disease With Comorbid Coronary Artery Disease and Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease, run by Ruijin Hospital at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03977129, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.