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

Phase 4

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT00406523
• Lead Sponsor: Shenyang Northern Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Status Verified: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Last Update Submitted: 2006-11-30
• Study First Posted: 2006-12-04
• Last Update Posted: 2006-12-04
• Study Completion: 2007-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL