KCT0009073
Not yet recruiting
未知
A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery Disease
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Asan Medical Center
- Enrollment
- 934
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject must be \=20 years of age with angina and/or evidence of myocardial ischemia
- •2\. Significant de novo LMCA disease, defined as \= 50% diameter stenosis by visual estimation with or without concomitant non\-left main major epicardial CAD, amenable to PCI with DES implantation.
- •3\. 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\.Extremely calcified or tortuous vessels precluding FFR measurement
- •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 STEMI (\<7 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 surgical procedure (e.g., valve replacement or aorta surgery)
- •7\.Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel)
- •8\.Prior PCI of the left main trunk
- •9\.Prior CABG
- •10\.Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year
Outcomes
Primary Outcomes
Not specified
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