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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01373645
First received: April 1, 2011
Last updated: July 27, 2015
Last verified: October 2008
  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

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


Enrollment: 1045
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT01373645

Locations
China, Shanghai
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

Publications:
Responsible Party: Weifeng Shen, Ruijin hospital, shanghai jiao tong university school of medicine
ClinicalTrials.gov Identifier: NCT01373645     History of Changes
Other Study ID Numbers: RJH20100909 
Study First Received: April 1, 2011
Last Updated: July 27, 2015
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 August 29, 2016