Quantitative Flow ReserveQFR-RADIALNCT07669987
The Impact of Preoperative Quantitative Flow Reserve (QFR) on Early Postoperative Radial Artery Graft Outcomes in Coronary Artery Bypass Grafting
An observational study of Quantitative Flow Reserve and Minimally Invasive Coronary Surgery, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the long-term effects of Quantitative Flow Reserve (QFR) assessment in patients undergoing Coronary Artery Bypass Grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quantitative Flow Reserve, Minimally Invasive Coronary Surgery, Radial Artery
- What is being tested?
- Observational
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project aims to prospectively enroll patients undergoing coronary artery bypass grafting (CABG) utilizing the radial artery as a conduit at Peking University Third Hospital from January 2023 to September 2025.
Who may be able to join
- Patients aged 18 to 80 years.
- Patients whose angina pectoris significantly affects daily life and work, and for whom conservative medical treatment is ineffective, requiring coronary artery bypass grafting (CABG).
- Preoperative coronary angiography data are available for quantitative flow ratio (QFR) analysis.
- Patients with severe stenosis, defined as greater than 70% stenosis, in the three main coronary artery branches, including the left anterior descending artery, circumflex artery, and right coronary artery, with or without left main coronary artery stenosis greater than 50%.
Who cannot join
- Patients who cannot tolerate CABG due to comorbidities or complications.
- Patients requiring urgent CABG or percutaneous coronary intervention (PCI).
- Patients with significant congestive heart failure or hemodynamic instability.
- Patients with a history of previous CABG or PCI within the past 6 months.
- Patients who have experienced a stroke within the past 6 months.
- Patients requiring concurrent cardiac procedures, such as valve surgery, maze surgery, radiofrequency ablation, or pacemaker implantation.
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- Patients with allergies to contrast agents or antiplatelet medications, or with contraindications to antiplatelet medications due to bleeding risks.
- Patients with a significant history of bleeding, marked leukopenia, neutropenia, thrombocytopenia, anemia, or bleeding diathesis.
- Patients currently participating in other prospective clinical studies.
- Patients who are unwilling to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality, 100191
Tong Ding, 13132150173, dt1067723747@gmail.com
Yunpeng Ling, MD
About this study
The goal of this observational study is to learn about the long-term effects of Quantitative Flow Reserve (QFR) assessment in patients undergoing Coronary Artery Bypass Grafting (CABG). The main question it aims to answer is:
Does preoperative QFR measurement improve graft outcomes and reduce major adverse cardiac and cerebrovascular events (MACE) in patients undergoing CABG?
Participants who are scheduled for CABG and have undergone preoperative QFR assessment will be followed for one year post-surgery. They will provide data on graft patency and report any occurrences of MACE through regular follow-up visits and questionnaires about their health status.
- Being tested
- Observational
- Keywords
- Quantitative Flow Reserve, minimally invasive coronary surgery, Radial Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
The patency of the graft vessels one year postoperatively.
The patency of the radial artery graft in subjects who underwent coronary artery bypass grafting (CABG) one year postoperatively was assessed using coronary computed tomography angiography (CCTA) or conventional angiography (CAG), and its functional status was evaluated. Patency was classified according to the FitzGibbon classification system: Grade A indicates widely patent grafts, Grade B indicates grafts with limited flow (stenosis < 50%), Grade S denotes the presence of string sign (stenosis > 50% at any location of the graft), and Grade O signifies graft occlusion. Grades S and O were considered indicative of graft failure. The angiographic/CTA evaluations were conducted by two clinical physicians who were blinded to the preoperative quantitative flow ratio (QFR) values.
Measured: 12 months
Secondary outcomes (1)
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at one year post-surgery, including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quantitative Flow ReserveStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669987
- Sponsor's protocol ID
- QFR-RADIAL
- Other IDs
- BYSYZD2023015
- Acronym
- QFR-RADIAL
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Quantitative Flow Reserve (QFR) on Early Postoperative Radial Artery Graft Outcomes in Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT07669987
- Acronym / sponsor ID
- QFR-RADIAL / QFR-RADIAL
- Keywords
- Quantitative Flow Reserve, minimally invasive coronary surgery, Radial Artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term effects of Quantitative Flow Reserve (QFR) assessment in patients undergoing Coronary Artery Bypass Grafting (CABG). The main question it aims to answer is:
Does preoperative QFR measurement improve graft outcomes and reduce major adverse cardiac and cerebrovascular events (MACE) in patients undergoing CABG?
Participants who are scheduled for CABG and have undergone preoperative QFR assessment will be followed for one year post-surgery. They will provide data on graft patency and report any occurrences of MACE through regular follow-up visits and questionnaires about their health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project aims to prospectively enroll patients undergoing coronary artery bypass grafting (CABG) utilizing the radial artery as a conduit at Peking University Third Hospital from January 2023 to September 2025.
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years.
- Patients whose angina pectoris significantly affects daily life and work, and for whom conservative medical treatment is ineffective, requiring coronary artery bypass grafting (CABG).
- Preoperative coronary angiography data are available for quantitative flow ratio (QFR) analysis.
- Patients with severe stenosis, defined as greater than 70% stenosis, in the three main coronary artery branches, including the left anterior descending artery, circumflex artery, and right coronary artery, with or without left main coronary artery stenosis greater than 50%.
Key exclusion criteria (10 listed)
- Patients who cannot tolerate CABG due to comorbidities or complications.
- Patients requiring urgent CABG or percutaneous coronary intervention (PCI).
- Patients with significant congestive heart failure or hemodynamic instability.
- Patients with a history of previous CABG or PCI within the past 6 months.
- Patients who have experienced a stroke within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational study | Other | – |
Primary outcome
The patency of the graft vessels one year postoperatively.
Time frame: 12 months
The patency of the radial artery graft in subjects who underwent coronary artery bypass grafting (CABG) one year postoperatively was assessed using coronary computed tomography angiography (CCTA) or conventional angiography (CAG), and its functional status was evaluated. Patency was classified according to the FitzGibbon classification system: Grade A indicates widely patent grafts, Grade B indicates grafts with limited flow (stenosis < 50%), Grade S denotes the presence of string sign (stenosis > 50% at any location of the graft), and Grade O signifies graft occlusion. Grades S and O were considered indicative of graft failure. The angiographic/CTA evaluations were conducted by two clinical physicians who were blinded to the preoperative quantitative flow ratio (QFR) values.
1 secondary outcome
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at one year post-surgery, including all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, and repeat revascularization.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quantitative Flow Reserve and Minimally Invasive Coronary Surgery, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tong Ding, MD (+8613132150173, dt1067723747@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patency of the graft vessels one year postoperatively. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.