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De klinische studie NCT03977129 (FAVOR IV-QVAS) voor 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 is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease (FAVOR IV-QVAS)
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De klinische studie NCT03977129 (FAVOR IV-QVAS) is een interventioneel studie bij 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 met de status actief, niet rekruterend. Het doel is om 792 deelnemers te includeren vanaf 4 augustus 2019. De studie wordt geleid door Ruijin Hospital en de voltooiing is gepland op 1 augustus 2027. Laatste update op ClinicalTrials.gov: 17 september 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel
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
Aandoeningen
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 DiseasePublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- FAVOR IV-QVAS
- 2018CR001
NCT-ID
Startdatum (Werkelijk)
2019-08-04
Laatste update geplaatst
2025-09-17
Verwachte einddatum
2027-08
Inschrijving (Geschat)
792
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelQFR 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. |
Actieve comparatorCAG 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. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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 HospitalMed-X Research Institute, Shanghai Jiao Tong UniversityVerantwoordelijke instantie
Qiang Zhao,MD, Hoofdonderzoeker, Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital
Geen contactgegevens beschikbaar
12 Studielocaties in 1 landen
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