None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : This study was designed to evaluate the efficacy of CGBIO stent and Biomatrix flex stent in patients undergoing coronary artery disease, such as stable angina pecto
Sponsors
CGBio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with significant coronary artery stenosis (> 50% diameter stenosis on coronary angiography) 2. Subjects with stable angina, unstable angina, asymptomatic myocardial ischemia, and non-ST-elevated myocardial infarction (NSTEMI) 3. Subjects eligible for coronary stenting 4. Subjects with a lesion length of less than 40 mm and a coronary artery diameter of greater than or equal to 2.25 mm and less than 4.0 mm on the coronary angiography screening at the screening stage (except for lesions not covered by the procedure) 5. Subjects with satisfactory TIMI (thrombolysis in myocardial infarction) flow grade 1 or higher on the coronary angiogram 6. Subjects who could use up to two stents (CGBIO stent: length 38 mm or less, control group: BioMatrix length 36 mm or less) 7. One-vessel percutaneous coronary intervention (PCI) * Includes 2VD or 3VD patient or even one target lesion 8. Subjects aged 20 years or older and younger than 80 years 9. Those who voluntarily agreed to participate in this trial and provided written consent
Exclusion criteria
Exclusion criteria: 1. Subjects with acute myocardial infarction [acute Q-wave myocardial infarction (STEMI) within 72 hours] 2. Subjects experiencing cardiogenic shock 3. Subjects with chronic total occlusion 4. Subjects with restenosis lesion 5. Subjects with a left main canal lesion 6. Subjects with graft vessel lesions 7. Subjects with systemic bleeding disorder, coagulation disorder 8. Subjects with expected life expectancy within 1 year due to accompanying disease 9. Subjects with contraindications to Aspirin, Clopidogrel, Heparin, Sirolimus, Biolimus A9 10. Patients who have been treated with Drug-eluting stent (DES) or Drug-eluting balloon (DEB) containing Sirolimus, Paclitaxel, or Biolimus A9 within 12 months prior to clinical study or who have been treated with Bare-metal stent (BMS) 11. Pregnant women, lactating women, women who do not consent to the appropriate use of contraception during the trial - Proper contraceptive methods: Infertility surgery, hormonal contraceptive methods (subcutaneous implants, injections, oral contraceptives, etc.), intrauterine devices (copper loop, hormone containing intrauterine system) 12. Platelets (100 103 / µL), Platelets (700 103 / µL), AST and ALT> 5.0 x ULN (WBC < , Creatinine> 2.0 mg / dL 13. Those who have had intracranial bleeding within 6 months before participating in the clinical trial 14. Subjects with or without medical conditions, such as cardiovascular, digestive, respiratory, endocrine, and central nervous system disorders, such as mental illness, 15. Patients with autoimmune disease (such as systemic lupus erythematosus) who are receiving oral or intravenous immunosuppressant therapy or those with acquired immunodeficiency 16. Those who have participated in other clinical trials within four weeks prior to screening and have been or are currently participating in a drug or medical device (provided that they have participated in observational studies that do not involve treatment or treatment and maintain the concomitant therapy permitted in this trial Can participate regardless of termination of the clinical trial.) 17. Any other person deemed inappropriate by the tester
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss in segmental | — |
Secondary
| Measure | Time frame |
|---|---|
| Late lumen loss in stent;Intra-stent restenosis and intra-segment restenosis;Restenosis aspect;Change in intimal hyperplasia;Late stent malapposition incidence;Total mortality;Psychogenic mortality;Incidence of myocardial infarction;Incidence of target vessel revascularization;Incidence of target lesion re-treatment;Rate of stent thrombosis (based on ARC);Success rate of procedure;Adverse events;laboratory test;Vital signs;Electrocardiographic findings | — |
Countries
Korea, Republic of
Contacts
Public ContactHa-Na Lee
Seoul National University Hospital
Outcome results
None listed