Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent

Shanghai Jiao Tong University School of Medicine1 site in 1 country200 target enrollmentMay 2010

ConditionsCoronary Artery Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Shanghai Jiao Tong University School of Medicine
Enrollment: 200
Locations: 1
Primary Endpoint: late lumen loss
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

December 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

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%,

Outcomes

Primary Outcomes

late lumen loss

Time Frame: 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.