Safety and Efficacy Registry of Yinyi Stent (SERY-II)
Phase 2
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Yinyi stent
- Registration Number
- NCT01373658
- 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
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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 -
- Primary Outcome Measures
Name Time Method late lumen loss 12 months Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.
- Secondary Outcome Measures
Name Time Method major adverse cardiac events 12 months including cardiac death, re-infarction, and target vessel revascularization
Trial Locations
- Locations (1)
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
🇨🇳Shanghai, Shanghai, China