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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01373658
First received: April 1, 2011
Last updated: June 13, 2011
Last verified: March 2010

April 1, 2011
June 13, 2011
May 2010
October 2011   (final data collection date for primary outcome measure)
late lumen loss [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
No Changes Posted
major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
including cardiac death, re-infarction, and target vessel revascularization
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Registry of Yinyi Stent (SERY-II)
Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Device: Yinyi stent
subjects with Yinyi stent implantation
Experimental: Yinyi stent
Intervention: Device: Yinyi stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
December 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01373658
RJH20100910
No
Not Provided
Not Provided
Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Ruiyan Zhang, MD Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP