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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406523
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shenyang Northern Hospital
  Purpose

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 of restenosis in percutaneous coronary intervention (PCI) real world and to observe the safety and efficacy of 4 months’clopidogrel treatment after implantation of JANUS stent.

Patients were enrolled and randomized to be treated by JANUS or SRNCRO (bare metal stent with the same platform as JANUS). All enrolled patients received daily clopidogrel for 4 months and aspirin for life long for post-PCI period(In AMI group, patients received daily clopidogrel 150mg for 2 weeks at first). The primary endpoints included death of heart, myocardial infarction, revascularization of the target lesson, sub-acute and late stent thrombosis one year after PCI, The secondary endpoints included MACE at 30 days, 6 months and restenosis by follow-up angiogram at 6 to 12 months.


Condition Intervention Phase
Coronary Heart Disease Device: JANUS Stent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Study Start Date: February 2006
Estimated Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406523


Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, M.D. Shenyang Northern Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00406523     History of Changes
Other Study ID Numbers: NH-2006-B003
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases