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

Coronary Artery Disease Clinical Trial

— SERY-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01373658
• Other study ID #: RJH20100910
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 1, 2011
• Last updated: June 13, 2011
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ruiyan Zhang, MD
• Phone: 862164370045
• Email: zhangruiyan[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Yinyi stent
subjects with Yinyi stent implantation

Locations

Country	Name	City	State
China	ruijin hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	Yes
Secondary	major adverse cardiac events	including cardiac death, re-infarction, and target vessel revascularization	12 months	Yes