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Clinical Trials/NCT01373645
NCT01373645
Completed
Phase 2

Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent

Shanghai Jiao Tong University School of Medicine1 site in 1 country1,045 target enrollmentJanuary 2009
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ConditionsCoronary Artery Disease

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Shanghai Jiao Tong University School of Medicine
Enrollment
1045
Locations
1
Primary Endpoint
major adverse cardiac events
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai Jiao Tong University School of Medicine

Eligibility 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%,

Outcomes

Primary Outcomes

major adverse cardiac events

Time Frame: 12 months

including cardiac death, myocardial infarction and target vessel failure

Secondary Outcomes

  • stent thrombosis(12 months)

Study Sites (1)

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