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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:
ClinicalTrials.gov Identifier:
NCT01373658
First Posted: June 15, 2011
Last Update Posted: June 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Jiao Tong University School of Medicine
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373658


Contacts
Contact: Ruiyan Zhang, MD 862164370045 ext 665215 zhangruiyan@263.net

Locations
China, Shanghai
ruijin hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Ruiyan Zhang, MD    862164370045 ext 665215    zhangruiyan@263.net   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Ruiyan Zhang, MD Ruijin Hospital
  More Information

Responsible Party: Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine
ClinicalTrials.gov Identifier: NCT01373658     History of Changes
Other Study ID Numbers: RJH20100910
First Submitted: April 1, 2011
First Posted: June 15, 2011
Last Update Posted: June 15, 2011
Last Verified: March 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases


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