Coronary Artery Disease
Conditions
Brief summary
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.
Interventions
DEVICEYinyi stent
subjects with Yinyi stent implantation
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18-80 years old * both gender * native coronary lesion * narrowing \> 70% * vessel size 2.5-4.0 in diameter
Exclusion criteria
* without informed consent, * ST elevation myocardial infarction within 7 days, * patient with ≤ 70% coronary narrowing at target lesion, * left main lesion, * multivessel narrowing need more than 3 stent implantations, * by-pass graft, * abnormal liver function before randomization, * active hepatitis or muscular disease, * impaired renal function with serum creatinine level \> 3mg/dl, * impaired left ventricular function with LVEF \< 30%, * Participate in other studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiac events | 12 months | including cardiac death, myocardial infarction and target vessel failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stent thrombosis | 12 months | according to ARC definition |
Countries
China
Outcome results
None listed