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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Firebird 2 sirolimus-eluting stent; Device: Excel sirolimus-eluting stent

• Registration Number: NCT01373632
• 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 Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several 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) with durable polymer, comparing with Excel SES.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-06
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Last Update Submitted: 2011-06-14
• Study First Posted: 2011-06-15
• Last Update Posted: 2011-06-15
• Primary Completion: 2012-06
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• age > 18 years
• male or un-pregnant 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 sirolimus-eluting stent	the patients who receive Firebird 2 stent
Excel stent group	Excel sirolimus-eluting stent	the patients who receive Excel stent

Primary Outcome Measures

Name	Time	Method
in-stent late lumen loss at 9 months' angiographic follow-up	9 months	patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed

Secondary Outcome Measures

Name	Time	Method
target vessel failure	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