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

Sponsored by:	Shenyang Northern Hospital
Information provided by:	Shenyang Northern Hospital
ClinicalTrials.gov Identifier:	NCT00406523

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 IV

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009