None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women and men who are aged =19 2. Those who are suspected of stable angina and need percutaneous coronary intervention 3. Those who voluntarily decided to participate in this clinical trial and agreed in writing to the informed consent form 4. Those who are willing to comply with the protocol Angiographic Inclusion Criteria: 5. If the target lesion is a single lesion. 6. If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated. 7. If the diameter of the lesioned vessel to be treated by coronary angiography (target vessel) is between 2.5 mm and 4.5 mm (by visual estimate). 8. If diameter stenosis of the target vessel =50% (by visual estimate)
Exclusion criteria
Exclusion criteria: General Exclusion Criteria: 1. Those with a left ventricular ejection fraction (LVEF) = 30% 2. Those who have a history of hypersensitivity to contrast agents such as stainless steel, cobalt-chromium, etc. 3. Those who cannot stop taking antithrombotic drugs (anticoagulants, antiplatelet drugs) 4. Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia 5. Those who have a history of bleeding diathesis or coagulopathy or who refuse transfusion 6. Those with a history of stroke (CVA) or transient ischemic attack (TIA) within 4 weeks from the screening date 7. .Those with a history of active peptic ulcer or upper gastrointestinal bleeding within 24 weeks from the screening date 8. Those with ST-elevation myocardial infarction (STEMI) (for example, those who started myocardial infarction symptoms within 72 hours from the screening date) 9. Those with a history of cardiogenic shock or cardiac arrest 10. Those who underwent coronary artery bypass grafting (CABG) 11. Those who underwent percutaneous coronary intervention (PCI) within 72 hours from the screening date 12. Those who had a major adverse coronary event (MACE) or a serious adverse event (SAE) after receiving the percutaneous coronary intervention (PCI) within 4 weeks from the screening date 13. Those who are scheduled to undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 4 weeks from the end of this clinical trial 14. Those diagnosed with renal failure or those who are not suitable for angiography due to severe renal dysfunction (creatine >2.0 mg/dL or eGFR (estimated glomerular filtration rate) <30 ml/min) within one week prior to the date of coronary angiography 15. Pregnant and breastfeeding women 16. Women of childbearing potential who plan to become pregnant during this clinical trial 17. A woman* or spouse who is likely to be pregnant does not agree to use contraception in medically acceptable method of contraception** during the clinical trial 18. Those who are currently participating in other clinical trials or have experience participating in other clinical trials within 12 weeks from the screening date.However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion -Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial -Screening failed before any interventional factor is involved-Participated in academic trials like strategic or medical device comparison 19. Other cases where the investigator determines that participation in a clinical trial is inappropriate ethically or because it may affect the study outcome. Angiographic Exclusion Criteria: 20. Those who require manual or mechanical thrombectomy, rotational atherectomy, directional coronary atherectomy (DCA), etc. in addition to stent placement and balloon dilatation 21. When the two-stent technique is required for the side branch of the target bifurcation lesion. 22. When the investigator determines that PCI is not suitable because the target lesion hasany of the following characteristics: ?he target lesion is a chronic total occlusion (CTO) or total occlusion ?An ostial lesion in location ?The target vessel has evidence of intraluminal thrombus ?Moderate or severe calcification at the target lesion or near the target lesion ?If PCI cannot be performed for other reasons 23. If the investigator determines that the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is assessed through the occurrence of treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACE) that occur in the study subjects during the clinical trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The evaluation variables for demonstrating efficacy are 'clinical success rate (N%)', 'technical success rate (N%)', 'patient radiation time (min)', 'patient radiation exposure (Gy)', 'operator radiation exposure (mSv)' and 'procedure duration (min)', ‘total amount of contrast volume (ml)'.;If necessary, subgroup analysis based on the approach route for percutaneous coronary intervention (PCI) (femoral artery, radial artery) may be conducted. | — |
Countries
Korea, Republic of
Contacts
Public ContactJung-Hwa Lee
Asan Medical Center
Outcome results
None listed