Coronary Artery Disease
Conditions
Interventions
Experimental group:BIOMAGIC absorbable stent was implanted
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. General inclusion criteria: (1) Male or non-pregnant female aged between 18 and 75 years; (2) Qualified candidates who must perform CABG surgery; (3) The subject agrees not to participate in other clinical trials until the end point of this trial is reached; (4) The subject/legally authorized representative understands the purpose and procedure of the experiment and signs the informed consent voluntarily. 2. Inclusion criteria of angiography: (1) A single target lesion on a single target vessel; (2) The target lesion must be located in the autogenous coronary artery, with visual or quantitative evaluation of %DS>=50%, and =1; (3) Dmax>=2.75 mm and =2.75 mm and <=3.25 mm from visual measurement (online QCA measurement is recommended); (4) The visual length of the target lesion or the length measured by online QCA must be less than or equal to 20 mm.
Exclusion criteria
Exclusion criteria: 1. General exclusion criteria: (1) Lactating subjects, or subjects of childbearing age (15-50 years old) who plan to become pregnant and lactate within 2 years after the initial operation; (2) Cardiogenic shock; (3) Severe heart failure (NYHA Grade ? or above) or known subjects with left ventricular ejection fraction (LVEF) =B, or the subject had an estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m^2 at screening or was on dialysis; (18) The subject is on immunosuppressive therapy or has a known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus infection, systemic lupus erythematosus, etc.); Note: Immunosuppressive therapy does not include hormone therapy; (19) Subjects participating in other drug or device clinical trials do not meet the primary study endpoint; (20) The subject is unable or unwilling to participate in the test; (21) Subjects have conditions that the investigator deems unsuitable for this study. 2. Exclusion criteria of angiography: (1) The target lesion was located in the left main trunk; (2) Target lesions of the right coronary artery (RCA) located at the aortic ope
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lose of lesion segment;Target lesion failure;Device oriented composite endpoints; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate;Patient oriented composite endpoint ;Thrombosis in scaffold;Major adverse cardiovascular events;Angiography secondary end point; | — |
Countries
China
Contacts
Public ContactMiao Yongsheng
Shanghai BIOMAGIC Medical Device CO., Ltd.
Outcome results
None listed