Recruiting

PCI vs. CABG

Sponsor:

Duk-Woo Park, MD

Code:

NCT05831085

Conditions

Coronary Artery Stenosis

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

State-of-the-Art Percutaneous Coronary Intervention

standard CABG

Study Details

Brief summary:

The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).

Conditions

Coronary Artery Stenosis

Study ID

NCT05831085

Start date

Jun 14, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
2. Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL \[7.0 mmol/L\] or 2-h postprandial of ≥200 mg/dL \[11.1 mmol/L\] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL \[11.1 mmol/L\] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% \[48 mmol/mol\]).
3. Significant three-vessel CAD (defined as ≥ 50% diameter stenosis \[DS\] by visual estimation in each of the three major epicardial vessels or major side branches but not involving the left main coronary artery) and equivalently amenable to revascularization by means of either PCI or CABG as determined by the Heart Team at the trial site.
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Unprotected left main coronary artery disease.
2. The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone).
3. Recent ST-elevation myocardial infarction(<5 days prior to randomization).
4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
5. Severe left ventricular dysfunction (ejection fraction <30%).
6. Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed.
7. Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
8. Prior CABG.
9. Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
10. More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
11. Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
12. End-stage renal disease requiring renal replacement therapy.
13. Liver cirrhosis.
14. Pregnant and/or lactating women.
15. Concurrent medical condition with a limited life expectancy of less than 2 years.
16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;

1\) Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial.

2\) Screening failed before any interventional factor is involved.

3\) Participated in academic trials like strategic comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies.

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

active comparator: Coronary-Artery Bypass Grafting

Interventions

State-of-the-Art Percutaneous Coronary Intervention

supported by intracoronary imaging (e.g., intravascular ultrasound \[IVUS\] or optical coherence tomography \[OCT\]), intracoronary physiology (e.g., fractional flow reserve \[FFR\] or instantaneous wave-free ratio \[iFR\]), contemporary metallic DES (durable polymer everolimus-eluting stents; XIENCE family stent system, Abbott Vascular), guideline-directed optimal medical therapy \[GDMT\] with advanced cardiovascular (e.g., high-dose statin and advanced strategy of antiplatelet regimens) and anti-diabetic medications \[e.g., a sodium-glucose cotransporter \[SGLT\]-2 inhibitors or Glucagon-like peptide-1 \[GLP-1\] agonists) in patients with type 2 diabetes and three-vessel coronary artery disease (CAD) (not involving left main)

standard CABG

Coronary-Artery Bypass Grafting

Primary outcome measure

  • The event rate of major adverse cardiac or cerebrovascular events [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jung-hee Ham, Project manager

82-2-3010-4728cvcrc5@amc.seoul.kr

Locations

Palo Alto VA Medical Center

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Fearon F. William, MD

More Information

Sponsor

Duk-Woo Park, MD

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

  • Multivessel Coronary Artery Disease
  • state of the art
  • State-of-the-Art Percutaneous Coronary Intervention
  • Coronary-Artery Bypass Grafting
  • Diabetes Mellitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Duk-Woo Park, MD on 2026-06-24.