The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- The rate of graft patency
Study Overview
Brief Summary
Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.
Detailed Description
CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with evidence of angina pectoris
- •left main or three vessels disease, have the indication for CABG after discussion of the heart team
- •at least one main vessels stenosis on 40%-70%
Exclusion Criteria
- •former cardiac surgery patients
- •need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
- •emergent CABG
- •acute myocardial infarction time less than 7 days
- •life expectancy less than 3 years
Arms & Interventions
QFR-guided
This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR.
Intervention: QFR-guided CABG (Procedure)
Angio-guided
This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.
Intervention: Angio-guided CABG (Procedure)
Outcomes
Primary Outcomes
The rate of graft patency
Time Frame: 12 months
graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result
Secondary Outcomes
- Major adverse cardiovascular event(MACE)(12 months)
- The rate of angina relief(12 months)
Investigators
Dong Ran
Direcotr,chief of ward No.11, Department of cardiac surgery
Beijing Anzhen Hospital