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

Shanghai Jiao Tong University School of Medicine

Status and phase: Withdrawn; Phase 4

Conditions: Coronary Artery Stenosis

Treatments: Device: Cypher SES; Device: Firebird 2 SES

Study type: Interventional

Funder types: Other

Identifiers

NCT01328730

RJH20110331

Details and patient eligibility

About

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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Firebird 2 stent group

Experimental group

Description:

patients who were implated with Firebird 2 SES

Treatment:

Device: Firebird 2 SES

Cypher Stent Group

Active Comparator group

Description:

patients who were implanted with Cypher SES

Treatment:

Device: Cypher SES