Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
1 other identifier
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Feb 2017
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 7, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedDecember 11, 2018
December 1, 2018
2.9 years
December 7, 2018
December 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of graft patency
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
12 months
Secondary Outcomes (2)
Major adverse cardiovascular event(MACE)
12 months
The rate of angina relief
12 months
Study Arms (2)
QFR-guided
EXPERIMENTALThis 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.
Angio-guided
ACTIVE COMPARATORThis group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team.
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ran Dong, MD
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Direcotr,chief of ward No.11, Department of cardiac surgery
Study Record Dates
First Submitted
December 7, 2018
First Posted
December 10, 2018
Study Start
February 1, 2017
Primary Completion
January 1, 2020
Study Completion
August 30, 2020
Last Updated
December 11, 2018
Record last verified: 2018-12