- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770520
Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
December 9, 2018 updated by: Dong Ran, Beijing Anzhen Hospital
The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
208
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yang Zhao, MD
- Phone Number: 13810050821
- Email: allen_hya731@sohu.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- Beijing Anzhen Hospital
-
Contact:
- Yang Zhao, MD
- Phone Number: 86-10-64456411
- Email: allen_hya731@sohu.com
-
Principal Investigator:
- Ran Dong, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
CABG surgery based on CAG and QFR
|
Active Comparator: 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.
|
CABG surgery based on heart team discussion of CAG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiovascular event(MACE)
Time Frame: 12 months
|
The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
|
12 months
|
The rate of angina relief
Time Frame: 12 months
|
whether angina is relieved will be evaluated
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ran Dong, MD, Beijing Anzhen Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
August 30, 2020
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (Actual)
December 10, 2018
Study Record Updates
Last Update Posted (Actual)
December 11, 2018
Last Update Submitted That Met QC Criteria
December 9, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z171100001017059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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