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Coronary Artery DiseaseCtaCABNCT07769008

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

A study testing CCTA-based CABG and CAG-based CABG in people with Coronary Artery Disease and Coronary Artery Bypass Grafting, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CCTA-based CABG and CAG-based CABG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
826 participants
Where
1 siteChina
Study dates
17 Aug 2026to Aug 2029
Phase
Interventional

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Referred to CABG treatment

Who cannot join

  • Under the age of 18 years
  • Unable to provide informed consent
  • Emergency CABG
  • Redo-CABG
  • Prior PCI with coronary stent implantation
  • Cardiogenic shock
Show all 10Show fewer
  • Unable to undergo CAG or CCTA examination or deemed unsuitable by the investigator, such as:
  • Known allergy to iodinated contrast media; Active hyperthyroidism or uncontrolled thyroid disease; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²; Atrial fibrillation with rapid ventricular response or severe arrhythmias not amenable to rate control;
  • Pregnancy, lactation, or childbearing potential without effective contraception in female participants
  • Concurrent participation in another interventional trial

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
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai

    Yunpeng Zhu, MD, 0086-02164370045, zyp12220@rjh.com.cn

    Yunpeng Zhu, MD

    Recruiting

Other trials in China

About this study

Official title: Coronary Computed Tomography Angiography-Based Versus Coronary Angiography-Based Coronary Artery Bypass Grafting: A Multicenter Pragmatic Non-Inferiority Randomized Controlled Trial

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:

Read more

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

Being tested
CCTA-based CABG, CAG-based CABG
Keywords
Major Adverse Cardiovascular Events (MACE), Coronary Artery Bypass Grafting (CABG), Coronary Computed Tomography Angiography(CCTA), Coronary Angiography(CAG)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCTA-based CABGProcedure or surgery

    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 CABGProcedure or surgery

    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 groups in NCT07769008
Study groupRoleWhat they receive
CCTA-Based CABGExperimentalNot described
Receives: Procedure: CCTA-based CABG
CAG-Based CABGActive comparatorNot described
Receives: Procedure: CAG-based CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)

    The 5P-MACE was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and CABG-related or cardiovascular-related prolonged postoperative length of stay (PLOS) or rehospitalization.

    Measured: Within 1 year post-CABG

Secondary outcomes (10)
  1. 1-year incidence of all-cause death

    Measured: Within 1 year post-CABG

  2. 1-year incidence of CV death

    Measured: within 1 year post-CABG

  3. 1-year incidence of MI

    Measured: Within 1 year post-CABG

  4. 1-year incidence of stroke

    Measured: Within 1 year post-CABG

  5. 1-year incidence of unplanned revascularization

    Measured: Within 1 year post-CABG

  6. 1-year incidence of CABG-related or CV-related prolonged PLOS or rehospitalization.

    Measured: Within 1 year post-CABG

  7. 30-day incidence of the operative mortality and morbidity

    The operative mortality and morbidity was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, cardiac arrest, reoperation, prolonged ventilation, deep sternal wound infection, pacemaker implantation, major gastrointestinal bleeding, and new dialysis .

    Measured: Within 30 days post-CABG

  8. 7-day graft failure rate

    Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.

    Measured: At 7 day post-CABG

  9. 1-year graft failure rate

    Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.

    Measured: At 1 year post-CABG

  10. Other serious adverse events (SAE)

    Important medical events that impact subjects' daily life or health and require appropriate intervention, but are not part of the primary or secondary outcome definitions above

    Measured: Within 1 year post-CABG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2026
  2. Study start17 Aug 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
826 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07769008
Sponsor's protocol ID
KY-2026-523
Acronym
CtaCAB
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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