Safety and Efficacy Registry of Yinyi Stent
Phase 2
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Yinyi stent
- Registration Number
- NCT01373645
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1045
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Yinyi stent Yinyi stent subjects with Yinyi stent implantation
- Primary Outcome Measures
Name Time Method major adverse cardiac events 12 months including cardiac death, myocardial infarction and target vessel failure
- Secondary Outcome Measures
Name Time Method stent thrombosis 12 months according to ARC definition
Trial Locations
- Locations (1)
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
🇨🇳Shanghai, Shanghai, China