Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

Coronary Artery Disease Clinical Trial

Official title:

The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770520
• Other study ID #: Z171100001017059
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: December 2018
• Source: Beijing Anzhen Hospital
• Contact: Yang Zhao, MD
• Phone: 13810050821
• Email: allen_hya731[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: August 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• QFR-guided CABG
CABG surgery based on CAG and QFR
• Angio-guided CABG
CABG surgery based on heart team discussion of CAG

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Major adverse cardiovascular event(MACE)	The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization	12 months
Secondary	The rate of angina relief	whether angina is relieved will be evaluated	12 months