None listed
Conditions
Interventions
Medical Device : If the tester determines that the medical device for this clinical trial is suitable for treatment among patients who are treated with coronary artery disease, tiger DES stent, a medi
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 19 years old 2. Those with coronary artery disease such as stable angina, unstable angina, and silent myocardial ischemia who require minimally invasive percutaneous coronary intervention (PCI) 3. Those who meet all of the following conditions for coronary angiography 1) Significant coronary artery stenosis in new single vessels* (>50% diameter stenosis and evidence of objective ischemia, or fractional flow reserve (FFR) <0.80) *However, it may be included in patients with 2 vessel disease (VD) or 3VD, or when the target lesion is 1 2) A person whose length of the target lesion is 40 mm or less, and the diameter of the reference vessel is 2.25 mm or more and 4.00 mm or less and can apply a clinical trial medical device to the target lesion by coronary anatomy 3) thrombolysis in myocardial infarction (TIMI) flow grade 1 or higher behind the lesion 4. A person who can use up to two stents overlapping the target lesion 5. A person who is willing to participate in the test, observe treatment and procedures, and visit the hospital for all observational evaluations. 6. A person who voluntarily signs a written consent after hearing the explanation of the purpose and method of this clinical trial
Exclusion criteria
Exclusion criteria: 1. Those with the following past medical history or comorbid diseases 1) Patients with acute myocardial infarction 2) Those who have experienced psychogenic shock 3) Those with chronic total occlusion 4) Those with restenosis lesions 5) Those with left main coronary artery lesion 6) Those with graft vessel lesions 7) Those with a history of bleeding tendency or blood clotting disorder 8) Those who received cardiopulmonary resuscitation 9) Patients with severe renal impairment (estimated GFR <30 mL/min/1.73m2 and those undergoing dialysis at end stage renal failure or at the time of screening) 2. Those who have a record of less than 40% of the left ventricle ejection fraction (LVEF) within 6 months prior to screening 3. Patients who received PCI in target vessels within 1 year prior to participation in this clinical trial 4.Right coronary artery (RCA), left anterior descending (LAD), and left circumflex artery (LCx) with lesions within 3 mm of the origin Patients requiring surgery requiring discontinuation of antiplatelet drugs within 5.1 years 6. Those whose expected life expectancy is within 1 year due to the accompanying disease 7. Those who are contraindicated in antiplatelet (aspirin, clopidogrel, etc.) or anticoagulant therapy (heparin, etc.) 8. Those who have a lesion that is judged to be difficult to inflate an angioplasty balloon catheter 9. Those who have hypersensitivity or contraindications to stent alloy materials such as everolimus, cobalt chromium, titanium dioxide, and contrast agents 10. Pregnant and lactating women, or women of childbearing potential who have a pregnancy plan during the clinical trial period or who do not agree to the use of appropriate contraception ? Hormonal contraceptives (oral, grafting tablets, etc.), implantation of intrauterine devices or intrauterine systems, double blocking method (using both male condoms and closed caps (contraceptive diaphragms or cervical caps)), sterilization/surgery, abstinence 11. Those with reduced immunity 12. A person who has or currently has a medical condition such as a mental disorder that has a significant clinical disorder in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or has a significant effect on this clinical trial. 13.Persons who participated in other clinical trials within one month prior to participation in this clinical trial and received clinical trial drugs or used clinical trial medical devices 14. Those who, in the opinion of the investigator, are not suitable for clinical trials or may increase the risk associated with participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In segment late lumen loss in segment after application of clinical trial medical device evaluated by independent evaluator | — |
Secondary
| Measure | Time frame |
|---|---|
| in-segment % diameter stenosis;in-stent % diameter stenosis);in-segment binary restenosis;in-stent binary restenosis;cardiac death;Myocardial infarction;target lesion revascularization, TLR;target vessle revascularization, TVR;stent thrombosis | — |
Countries
Korea, Republic of
Contacts
Public ContactGeun Young Jang
Chonnam National University Hospital
Outcome results
None listed