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
NCT ID: NCT05831085
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-06-14
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention
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)
Coronary-Artery Bypass Grafting
standard CABG
Coronary-Artery Bypass Grafting
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Duk-Woo Park, MD
OTHER
Responsible Party
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Duk-Woo Park, MD
Professor, Cardiology, Asan Medical Center Heart Institute, Valvular Heart Disease Center, Ischemic Heart Disease Center
Principal Investigators
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Seung-jung Park, MD
Role: STUDY_CHAIR
Asan Medical Center
Locations
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Palo Alto VA Medical Center
Palo Alto, California, United States
Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, , China
Sarawak Heart Centre
Kota Samarahan, , Malaysia
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Dong-A Medical Center
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
National Taiwan University Hospital
Taipei, , Taiwan
Siriraj Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Fearon F. William, MD
Role: primary
Jian'an Wang, MD
Role: primary
Alan Pong, MD
Role: primary
Jin-bae Lee, MD
Role: primary
Chul-hyun Lee, MD
Role: primary
Woong Kim, MD
Role: primary
Jin-ok Jeong, MD
Role: primary
Taek-keun Kwon, MD
Role: primary
Han-bit Park, MD
Role: primary
Young-keun Ahn, MD
Role: primary
Ji-yong Jang, MD
Role: primary
Seung-hwan Han, MD
Role: primary
Yong-rak Cho, MD
Role: primary
Duk-woo Park, MD
Role: primary
Young-hyo Lim, MD
Role: primary
Hyo-seok Ahn, MD
Role: primary
Eun-seok Shin, MD
Role: primary
Paul Hsien Li Kao, MD
Role: primary
Karokoth Towashiraporn, MD
Role: primary
Other Identifiers
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AMCCV2023-03
Identifier Type: -
Identifier Source: org_study_id