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Clinical Trials in India / NCT05831085
Recruiting

Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

NCT05831085 · tracked via the Priya Life Science India tracker
Sponsor
Duk-Woo Park, MD
Phase
N/A
Started
2024-06-14
Last updated
2026-06-24

Condition(s) studied

Coronary Artery Stenosis

Investigational drug(s) / intervention(s)

State-of-the-Art Percutaneous Coronary Interventionstandard CABG

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

Study 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).

Eligibility

Sex
ALL
Min age
20 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Palo Alto VA Medical Center Palo Alto California Recruiting
Victorian Heart Institute Clayton Australia Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences (CAMS) Beijing China Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine Hanzhou China Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
Mody Harvard Cardiac Institute Bathinda India Recruiting
Medanta - The Medicity Gurugram India Recruiting
Fortis Escorts Heart Institute New Delhi India Recruiting
Tsuchiura Kyodo Hospital Tsuchiura Japan Recruiting
Pauls Stradins Clinical University Hospital Riga Latvia Recruiting
Vilnius University Hospital Santaros Klinikos Vilnius Lithuania Recruiting
Sarawak Heart Centre Kota Samarahan Malaysia Recruiting
University Clinical Center of Serbia Belgrade Serbia Recruiting
National Heart Centre Singapore (NHCS) Singapore Singapore Recruiting
Bucheon Sejong Hospital Bucheon-si South Korea Recruiting
Daegu Catholic University Medical Center Daegu South Korea Not Yet Recruiting
Keimyung University Dongsan Medical Center Daegu South Korea Recruiting
Yeungnam University Medical Center Daegu South Korea Not Yet Recruiting
Chungnam National University Hospital Daejeon South Korea Recruiting
Konyang University Hospital Daejeon South Korea Withdrawn
Gangneung Asan Hospital Gangneung South Korea Not Yet Recruiting
Chonnam National University Hospital Gwangju South Korea Recruiting
National Health Insurance Service Ilsan Hospital Ilsan South Korea Recruiting
Gachon University Gil Hospital Incheon South Korea Not Yet Recruiting
Dong-A Medical Center Pusan South Korea Recruiting
Seoul university Bundang hospital Seongnam-si South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Hanyang University Seoul Hospital Seoul South Korea Not Yet Recruiting
Samsung Medical Center Seoul South Korea Recruiting
SNU Boramae Medical Center Seoul South Korea Not Yet Recruiting
The Catholic Univ. of Korea Seoul St. Mary's hospital Seoul South Korea Recruiting
The Catholic University of Korea, St. Vincent's Hospital Suwon South Korea Not Yet Recruiting
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital Uijeongbu-si South Korea Recruiting
Ulsan University Hospital Ulsan South Korea Recruiting
Pusan National University Yangsan Hospital Yangsan South Korea Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Siriraj Hospital Bangkok Thailand Recruiting
Siriraj Hospital Bangkok Thailand Recruiting
Srinagarind Hospital Khon Kaen Thailand Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05831085 on ClinicalTrials.gov ↗ ← All trials in India