Safety and Efficacy Registry of Yinyi Stent
SERY-I
1 other identifier
interventional
1,045
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started Jan 2009
Typical duration for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 29, 2015
October 1, 2008
2.9 years
April 1, 2011
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
major adverse cardiac events
including cardiac death, myocardial infarction and target vessel failure
12 months
Secondary Outcomes (1)
stent thrombosis
12 months
Study Arms (1)
Yinyi stent
EXPERIMENTALsubjects with Yinyi stent implantation
Interventions
Eligibility Criteria
You may qualify if:
- age 18-80 years old
- both gender
- native coronary lesion
- narrowing \> 70%
- vessel size 2.5-4.0 in diameter
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Zhang RY, Zhang Q, Zhu JZ, Chen LL, Zhang CY, Zhou XC, Yuan Y, Zhong ZX, Li L, Qiu J, Wang W, Chen XM, Yang ZJ, Yan JC, Chen SL, Hou YQ, Wu YQ, Luo HM, Qiu JP, Zhu L, Wang Y, Fu GS, Wang JA, Ma KH, Yin YH, Zhang DF, Hu XS, Zhu GY, Shen WF; Safety and Efficacy Registry of Yinyi stent (SERY-I) Investigators. Safety and efficacy of polymer-free paclitaxel-eluting microporous stent in real-world practice: 1-year follow-up of the SERY-I registry. Chin Med J (Engl). 2011 Nov;124(21):3521-6. No abstract available.
PMID: 22340171RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2011
First Posted
June 15, 2011
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 29, 2015
Record last verified: 2008-10