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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 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: March 2010
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:
  • 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.

Secondary Outcome Measures:
  • major adverse cardiac events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    including cardiac death, re-infarction, and target vessel revascularization

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yinyi stent 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: NCT01373658

Contact: Ruiyan Zhang, 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   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Principal Investigator: Ruiyan Zhang, MD Ruijin Hospital
  More Information

No publications provided

Responsible Party: Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine Identifier: NCT01373658     History of Changes
Other Study ID Numbers: RJH20100910
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 November 27, 2015