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New treatment option for Coronary Artery Stenosis
Official title 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
ClinicalTrials.gov ID: NCT05831085
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
- Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level...
- Significant three-vessel CAD (defined as ≥ 50% diameter stenosis [DS] by visual estimation in each of the three major epicardial vessels or major...
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by...
You likely can't join if
- Unprotected left main coronary artery disease.
- The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating treatment...
- Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
- Severe left ventricular dysfunction (ejection fraction \<30%).
- Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a...
See the full eligibility criteria
- The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia.
- 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...
- 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...
- 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...
- Unprotected left main coronary artery disease.
- The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating treatment cardiologist to believe that PCI is not suitable (i.e. the subject should...
- Recent ST-elevation myocardial infarction(\<5 days prior to randomization).
- Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support.
- Severe left ventricular dysfunction (ejection fraction \<30%).
- 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.
- Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or prasugrel) for at least 6 months.
- Prior CABG.
- Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation.
- More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed.
- people requiring or who may require additional surgery (cardiac or noncardiac) within 1 year.
- End-stage renal disease requiring renal replacement therapy.
- Liver cirrhosis.
- Pregnant and/or lactating women.
- Concurrent medical condition with a limited life expectancy of less than 2 years.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Clayton, Australia
- Beijing, China
- Hanzhou, China
- Hong Kong, Hong Kong
- Bathinda, India
- Gurugram, India
- New Delhi, India
- Tsuchiura, Japan
- Riga, Latvia
- Vilnius, Lithuania
- Kota Samarahan, Malaysia
- Belgrade, Serbia
- Singapore, Singapore
- Bucheon-si, South Korea
- Daegu, South Korea
- Daejeon, South Korea
- Gangneung, South Korea
- Gwangju, South Korea
- Ilsan, South Korea
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Clayton, Australia; Beijing, China; Hanzhou, China; Hong Kong, Hong Kong; Bathinda, India and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.