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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Information provided by:
Shanghai Jiao Tong University School of Medicine Identifier:
First received: April 1, 2011
Last updated: June 13, 2011
Last verified: October 2008

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 may prevent these complications.

Condition Intervention Phase
Coronary Artery Disease
Device: Yinyi stent
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    including cardiac death, myocardial infarction and target vessel failure

Secondary Outcome Measures:
  • stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    according to ARC definition

Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: November 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yinyi stent
subjects with Yinyi stent implantation
Device: Yinyi stent
subjects with Yinyi stent implantation


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01373645

Contact: Ruiyan Zhang, MD 862164370045 ext 665215
Contact: xin Chen, MD 862164370045 ext 665215

China, Shanghai
ruijin hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ruiyan Zhang,, MD    862164370045 ext 665215   
Principal Investigator: Ruiyan Zhang, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine Identifier: NCT01373645     History of Changes
Other Study ID Numbers: RJH20100909
Study First Received: April 1, 2011
Last Updated: June 13, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on October 23, 2014