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

Coronary Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406523
• Other study ID #: NH-2006-B003
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2006
• Last updated: November 30, 2006
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: November 2006
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Device:
• JANUS Stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital