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

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: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Procedure: QFR-guided CABG; Procedure: Angio-guided CABG

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

Study Locations

• China
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Procedure: QFR-guided CABG; 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.	Procedure: Angio-guided CABG; 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	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)	The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization	12 months
The rate of angina relief	whether angina is relieved will be evaluated	12 months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Municipal Science & Technology Commission
• Investigators: Study Director: Ran Dong, MD, Beijing Anzhen Hospital

Study record dates

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

• Keywords: Quantitative Flow Ratio; Coronary Artery Bypass Grafting; Graft patency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• 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