Status:

COMPLETED

A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease

Lead Sponsor:

Shenyang Northern Hospital

Conditions:

Coronary Heart Disease

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

Janus stent is the only marketed drug-eluting stent (DES) without polymer coating as yet in China. The goal of this study is to evaluate the efficacy of JANUS (Tacrolimus eluted stent) in inhibiting o...

Eligibility Criteria

Inclusion

  • Patients who were eligible for coronary stenting
  • All patients enrolled were implanted only one kind of stent
  • Stent number ≤ 8 per patient and ≤3 per vessel (stents overlapping part for 3~5mm and being fully post-dilated; Total stent length ≤ 85mm in same vessel)
  • Willing and able to sign informed consent.

Exclusion

  • Patients with multi-vessel disease could not be implanted the same kind of stent
  • In-stent restenosis target lesion
  • Patients not eligible for DES implantation (e.g. intolerance to anti-platelet therapy or undergoing heart or non-heart surgery recently

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

End Date :

September 1 2007

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00406523

Start Date

February 1 2006

End Date

September 1 2007

Last Update

December 4 2006

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A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease | DecenTrialz