Safety and Efficacy Registry of Yinyi Stent (SERY-II)

Phase 2

• Conditions: Coronary Artery Disease

• 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

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-05
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-06-13
• Last Update Submitted: 2011-06-13
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15
• Primary Completion: 2011-10
• Study Completion: 2011-12

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

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