The Impact of Preoperative Quantitative Flow Reserve (QFR) on Early Postoperative Radial Artery Graft Outcomes in Coronary Artery Bypass Grafting (QFR-RADIAL)

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 Overview

• Status: Recruiting
• Conditions: Radial Artery; Quantitative Flow Reserve; Minimally Invasive Coronary Surgery
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Tong Ding, MD; Phone Number: +8613132150173; Email: dt1067723747@gmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Tong Ding; Phone Number: 13132150173; Email: dt1067723747@gmail.com
      • Principal Investigator: Yunpeng Ling, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Radial Artery; minimally invasive coronary surgery; Quantitative Flow Reserve
• Additional Relevant MeSH Terms: Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: QFR-RADIAL; BYSYZD2023015 (Other Grant/Funding Number: Peking university third hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No