Text Size

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
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
History of Changes
  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
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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 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
ClinicalTrials.gov 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013