Anatomic versus Physiologic Guidance for Complete Revascularization with Drug Eluting Stent Implantation in Patients with Coronary Artery Disease
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007788
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 2400
1.Men or women between the ages of 18 and older
between the ages of 18 and 80
2.Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
3.Significant lesions with a diameter stenosis of 50-90% in major epicardial coronary arteries = 2.25 mm in diameter by visual estimation.
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.
1Angiographic exclusion criteria: any of the followings
1. Coronary lesions resulting in the expected inability to perform FFR (ex, severe tortuosity or extreme angulation of the vessels)
2. Chronic total occlusion
3. Failed PCI of severe stenotic (diameter stenosis > 90%) or ACS culprit lesions
2Previous PCI within 6 months before the index procedure
3Previous coronary artery bypass graft surgery
4Cardiogenic shock or hemodynamic instability
5Left ventricular dysfunction (ejection fraction < 35%)
6Life expectancy < 1 years for any non-cardiac or cardiac causes
7Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack or ischemic stroke within the past 6 months
8Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure
9A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
10Patient’s pregnant or breast-feeding or child-bearing potential.
11A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
12Hypersensitivity or contraindication to DES material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
13Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study.
14Unwillingness or inability to comply with the procedures described in this protocol.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point of the study is the rate of major adverse cardiac events (MACE) at 12 months. Major adverse cardiac events are defined as all-cause death, non-fatal myocardial infarction (MI)‡, and unplanned any coronary revascularization
- Secondary Outcome Measures
Name Time Method 1)The rate of each individual event, death (cardiac and all-cause), non-fatal MI, and unplanned repeat revascularization at the above time points 2)Death or non-fatal MI 3)Death from cardiovascular causes or non-fatal MI 4)Major or minor bleeding according to definitions from TIMI 5)Rehospitalization for an acute coronary syndrome or repeat PCI 6)Health-related quality of life (as measured by the Seattle Angina Questionnaire) 7)Procedure-related cost during index procedure