ClinicalTrials.gg
RecruitingNCT07769008CtaCABUpdated Oct 27, 2026

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

An interventional study of CCTA-based CABG and CAG-based CABG in Coronary Artery Disease, Coronary Artery Bypass Grafting and Coronary Computed Tomography Angiography, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 27, 2026Eligibility revisedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
826
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies in Coronary Artery Disease by Ruijin Hospital — 10 open to participants now, 11 under way, none of them phase 3. Coronary Artery Disease · Ruijin Hospital.

Started
2026
with 2 others
No phase
2 of 15
1 open now
Primary completion
2029-08
later than 10 of 10 live
Registered
15th of 15
by date

Among the 15 studies in Coronary Artery Disease by Ruijin Hospital, this one is one of 3 that started in 2026, is one of 2 with no phase, reaches primary completion later than 10 of the 10 other live ones, and was the 15th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

10 of the 15 studies in Coronary Artery Disease by Ruijin Hospital are open now, in 1 country. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Where they have run

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Coronary Artery Disease by Ruijin Hospital, or all of them as a file.
02

Study 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.

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

Read the detailed description

An internal pilot trial integrated with the main trial will enroll 80 participants to assess protocol adherence, recruitment efficiency, follow-up completion rates, and the overall feasibility of trial procedures. Provided that no major protocol amendments are made upon completion of the pilot phase, these 80 participants will be included in the primary analysis of the main trial.

The primary feasibility outcome include: initial screening success rate; informed consent completion rate; randomization completion rate following informed consent; recruitment rate(monthly recruitment number per site); rate of CABG planned and executed based solely on CTA; substantial concordance rate between planned and actually executed revascularization; 7-day postoperative CCTA follow-up completion rate, and 30-day clinical follow-up completion rate; and to explore the 7 day graft failure (Modified FitzGibbon grade B, S, or O), 30-day operative mortality and morbidity as clinical outcome.

03

Conditions studied

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

Keywords

  • Major Adverse Cardiovascular Events (MACE)
  • Coronary Artery Bypass Grafting (CABG)
  • Coronary Computed Tomography Angiography(CCTA)
  • Coronary Angiography(CAG)
04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Referred to CABG treatment

Exclusion criteria

Exclusion Criteria:

  • Under the age of 18 years
  • Unable to provide
  • Emergency CABG
  • Redo-CABG
  • Prior PCI with coronary stent implantation and unable to undergo photon counting CCTA.
  • Cardiogenic shock
  • 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 (eGFR) \< 30 mL/min/1.73 m²; Atrial fibrillation with rapid ventricular response or severe arrhythmias not amenable to rate control;

  • Pregnancy, lactation, or without effective in female participants
  • Concurrent participation in another interventional trial
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
826 participants (estimated)

Study arms

  • Experimental
    CCTA-Based CABG

    Procedure: CCTA-based CABG

  • Active comparator
    CAG-Based CABG

    Procedure: CAG-based CABG

Interventions

  • ProcedureCCTA-based CABG

    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.

  • ProcedureCAG-based CABG

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Within 1 year post-CABG

Secondary outcomes

  1. 1-year incidence of all-cause death

    Time frame: Within 1 year post-CABG

  2. 1-year incidence of CV death

    Time frame: within 1 year post-CABG

  3. 1-year incidence of MI

    Time frame: Within 1 year post-CABG

  4. 1-year incidence of stroke

    Time frame: Within 1 year post-CABG

  5. 1-year incidence of unplanned revascularization

    Time frame: Within 1 year post-CABG

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

    Time frame: 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 .

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: Within 1 year post-CABG

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2029, 36 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 36 months is close to that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 17, 2026
StartActual
Aug 17, 2026
Primary completionEst.
Aug 2029
CompletionEst.
Aug 2029
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedPrior PCI with coronary stent implantation and unable to undergo photon counting CCTA.
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedPrior PCI with coronary stent implantation and unable to undergo photon counting CCTA.
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07769008
Lead sponsor
Ruijin Hospital
Responsible party
Zhu yunpeng (Professor and Director of Clinical Research, Department of Cardiovascular Surgery, Ruijin Hospital) — Principal investigator
First posted
Aug 17, 2026
Start date
Aug 17, 2026
Primary completion
Aug 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
Oct 27, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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