A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
JANUS Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00406523
First Posted
November 30, 2006
Last Updated
November 30, 2006
Sponsor
Shenyang Northern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00406523
Brief Title
A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shenyang Northern Hospital
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
JANUS Stent
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, M.D.
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Single Center Prospective Randomized Controlled Clinical Study of JANUS Stent in Patients With Coronary Artery Disease
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