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

Shanghai Jiao Tong University School of Medicine200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Coronary Artery Disease

Interventions

Yinyi stentDEVICE

subjects with Yinyi stent implantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

late lumen loss

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.

Time frame: 12 months

Secondary Outcomes

major adverse cardiac events

including cardiac death, re-infarction, and target vessel revascularization

Time frame: 12 months

Central Contacts

Ruiyan Zhang, MD

CONTACT

862164370045 zhangruiyan@263.net

Data from ClinicalTrials.gov

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