A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery Disease
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009073
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 934
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.
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
11.End-stage renal disease requiring renal replacement therapy
12.Liver cirrhosis
13.Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
14.Concurrent medical condition with a limited life expectancy of less than 2 years
15.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;
a.Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial
b.Screening failed before any interventional factor is involved
c.Participated in academic trials like strategic or medical device 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
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome was the composite of death from any causes, MI, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest, or repeat revascularization at 2 years after randomization. Subjects who die or are lost to follow up before 2 years will be censored at their last recorded date.
- Secondary Outcome Measures
Name Time Method Each individual component of primary composite outcome;Death from any causes, cardiovascular causes, or noncardiovascular causes;MI (any, spontaneous or procedural);Composite of death or MI;Stent thrombosis (ARC definition);Stroke;Bleeding complications ;Procedure time;Amount of contrast agent used;Length of hospital stay;Rehospitalization (any, cardiac, or noncardiac causes);Functional class (assessed by the CCS Classification) at each time point (discharge and follow-up);Angina-related quality of life index (by the Seattle Angina Questionnaire [SAQ]);Health-related quality of life index (by the EQ-5D) at each time point (discharge and follow-up);Number of anti-anginal medications used at each time point (discharge and follow-up)