CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial

Sponsor
Ruijin Hospital
Study ID
NCT07769008
Status
Recruiting
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Conditions

  • Coronary Angiography (CAG)
  • Coronary Artery Bypass Grafting
  • Coronary Artery Disease
  • Coronary Computed Tomography Angiography

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CCTA-based CABG — PROCEDURE
    Surgical planning based solely on CCTA-derived data, including diameter stenosis (DS), area stenosis (AS), CT-derived fractional flow reserve (CT-FFR), LV:RV perfusion index, plaque characterization, 3D reconstruction of target vessels, and collateral circulation of chronic total occlusions (CTO) and so on. CCTA performed using photon-counting CT or conventional CT (≥64-slice, preferably ≥256-slice), following a standardized acquisition protocol. Images are transferred to an independent core laboratory for quantitative analysis and standardized reporting. The operating surgeon will not have access to CAG.
  • CAG-based CABG — PROCEDURE
    Surgical planning following standard practice using invasive coronary angiography(CAG). Angiograms obtained using a flat-panel detector system with standardized projections. The results of CAG are interpreted by the operating surgeon.The operating surgeon will not have access to CCTA.

Study Details

The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries. The main questions it aims to answer are: Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol. Participants will: Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well

Key Dates

First listed
Aug 17, 2026
Start date
Aug 17, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
826 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CCTA-Based CABG
  • Active Comparator: CAG-Based CABG

Primary Outcome Measure

1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE) [ Time Frame: Within 1 year post-CABG ]

Central Contacts

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