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NCT03977129Active, not recruiting

Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease

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

Source: ClinicalTrials.gov · Last updated 17 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
792 (actual)
First submitted
5 Jun 2019
Start date
4 Aug 2019
Primary completion date
30 Sept 2024
Lead sponsor
Ruijin Hospital
NCT number
NCT03977129

What you commit to

  • Study type: Interventional
  • Participants enrolled: 792
  • From 4 Aug 2019 to the primary completion date, 30 Sept 2024
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned valve intervention surgery through the catheter;

Other illness

  • History of heart surgery;
  • Secondary valvular heart disease (ischemia, cardiomyopathy);
  • 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);

Age

  • Life expectancy \< 3 years.

Other

  • Planned second-stage PCI or CABG revascularization;
  • The target coronary arteries were evaluated to be not suitable for CABG by study physician;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Qilu Hospital of Shandong University
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JinanChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Changhai Hospital of Shanghai
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ShanghaiChinaUnknown status
Tianjin Chest Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Fuwai Central China Cardiovascular Hospital
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ZhengzhouChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.