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

NCT03977129 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2025-09-17

No results posted yet for this study

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.

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

Interventions

DEVICE

QFR-guided strategy

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.

OTHER

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

Sponsors & Collaborators

  • Med-X Research Institute, Shanghai Jiao Tong University

    collaborator UNKNOWN

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Qiang Zhao, MD. · Ruijin Hospital

  • Shengxian Tu, PhD. · Med-X Research Institute, Shanghai Jiao Tong University

  • Yunpeng Zhu, MD. · Ruijin Hospital

  • Mario Gaudino, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-04
Primary Completion
2024-09-30
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03977129 on ClinicalTrials.gov