China Made Sirolimus Eluting Stent for Intermediate Lesion

Phase 2

• Conditions: Coronary Artery Disease
• Interventions: Device: China-made SES (Firebird 2 and Excel); Other: routine medicine

• Registration Number: NCT01375296
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(\> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-05
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-06-16
• Last Update Submitted: 2011-06-16
• Study First Posted: 2011-06-17
• Last Update Posted: 2011-06-17
• Primary Completion: 2011-10
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• age 18-80 years old
• both gender
• native coronary lesion
• narrowing 50-70%
• vessel size 2.5-4.0 in diameter

Exclusion Criteria

• without informed consent,
• ST elevation myocardial infarction within 7 days,
• left main lesion,
• by-pass graft,
• restenosis
• abnormal liver function before randomization,
• active hepatitis or muscular disease,
• impaired renal function with serum creatinine level > 3mg/dl ,
• impaired left ventricular function with LVEF < 30%,
• participate in other studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SES	China-made SES (Firebird 2 and Excel)	including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
medicine	routine medicine	-

Primary Outcome Measures

Name	Time	Method
target vessel failure	12 months	defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting \[CABG\] or repeated percutaneous transluminal coronary angioplasty \[PTCA\]).

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac events	12 months	including cardiac death, re-infarction and target vessel revascularization.

Trial Locations

Locations (1)

ruijin hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China