The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease

Phase 4

Withdrawn

• Conditions: Coronary Artery Stenosis
• Interventions: Device: Firebird 2 SES; Device: Cypher SES

• Registration Number: NCT01328730
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-04
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14
• Primary Completion: 2012-03
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• age > 18 years
• male or un-preganant female
• stenosis > 70% in one of major the epicardial coronary arteries
• no contra-indications of stent implantation
• singed the informed consent

Exclusion Criteria

• acute myocardial infarction within one week
• have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
• no history of stent implantation within last one-year
• received other brand coronary stent during index procedure
• with no achievement of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Firebird 2 stent group	Firebird 2 SES	patients who were implated with Firebird 2 SES
Cypher Stent Group	Cypher SES	patients who were implanted with Cypher SES

Primary Outcome Measures

Name	Time	Method
in-stent late lumen loss at 9 months' angiographic follow-up	9 months	Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 9 months

Secondary Outcome Measures

Name	Time	Method
target vessel failure	1, and 2 years after index procedure	defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting \[CABG\] or repeated percutaneous transluminal coronary angioplasty \[PTCA\]).

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China