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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:
Information provided by:
Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT00406523
First received: November 30, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406523

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

No publications provided

ClinicalTrials.gov Identifier: NCT00406523     History of Changes
Other Study ID Numbers: NH-2006-B003
Study First Received: November 30, 2006
Last Updated: November 30, 2006
Health Authority: China: Ministry of Health

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 May 23, 2013