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

Last updated: June 13, 2011
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Trial Status Unknown

Phase

2/3

Condition

Myocardial Ischemia

Coronary Artery Disease

Thrombosis

Treatment

N/A

Clinical Study ID

NCT01373658
RJH20100910
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18-80 years old

  • both gender

  • native coronary lesion

  • narrowing > 70%

  • vessel size 2.5-4.0 in diameter

Exclusion

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.

Study Design

Total Participants: 200
Study Start date:
May 01, 2010
Estimated Completion Date:
December 31, 2011

Connect with a study center

  • ruijin hospital, Shanghai Jiao Tong University, School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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