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L'essai clinique NCT03977129 (FAVOR IV-QVAS) pour 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 est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease (FAVOR IV-QVAS)

Actif, pas en recrutement
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L'étude clinique NCT03977129 (FAVOR IV-QVAS) est un essai interventionnel pour 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. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 4 août 2019 et vise à recruter 792 participants. Dirigé par Ruijin Hospital, l'essai devrait être terminé d'ici le 1 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 septembre 2025.
Résumé succinct
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.
Description détaillée
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.

Titre officiel

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

Conditions
Primary Valvular Heart Disease with Comorbid Coronary Artery DiseasePlanned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral And/or Aortic Valvular Heart Disease
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • FAVOR IV-QVAS
  • 2018CR001
Numéro NCT
NCT03977129
Date de début (réel)
2019-08-04
Dernière mise à jour publiée
2025-09-17
Date de fin (estimée)
2027-08
Inscription (estimée)
792
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalQFR group
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.
Comparateur actifCAG group
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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
within 30 days after surgery
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
within 1 year after surgery
The incidence of 1-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
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
within 3 years after surgery
The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis)
at 3 years after surgery
Health-related quality of life
the variables are the EQ-5D scores
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
within 30 days, 1 year and 3 years after surgery
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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.

  • 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.
Ruijin Hospital logoRuijin Hospital
Med-X Research Institute, Shanghai Jiao Tong University logoMed-X Research Institute, Shanghai Jiao Tong University
Partie responsable de l'essai
Qiang Zhao,MD, Investigateur principal, Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital
Aucune donnée de contact disponible
12 Centres de l'essai dans 1 pays

Anhui

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

Fujian

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Henan

Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

Hunan

The Second XiangYa Hospital of Central South University, Changsha, Hunan, China

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Shanghai Municipality

Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China
Changhai Hospital of Shanghai, Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China

Tianjin Municipality

Tianjin Chest Hospital, Tianjin, Tianjin Municipality, China

Zhejiang

The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China