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

Coronary Artery Stenosis Clinical Trial

— REFIRE  

Official title:

Post-marketing Study Comparing the Efficacy and Safety of Firebird 2 Versus Cypher Sirolimus-eluting Stents in Treating Patients With Coronary Artery Disease in China

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01328730
• Other study ID #: RJH20110331
• Status: Withdrawn
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: June 13, 2011
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2011
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institution of Cardiovascular Disease, Shanghai Jiaotong University School of Medicine: China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 430
• Est. completion date: June 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Firebird 2 SES
The FIREBIRD2™ Rapamycin-Eluting CoCr Coronary Stent is the second generation DES of MicroPort, which based on the new cobalt chromium alloy stent platform. It uses polyolefin polymer, which makes the coating property very remarkable.
• Cypher SES
The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-stent late lumen loss at 9 months' angiographic follow-up	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	9 months	Yes
Secondary	target vessel failure	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]).	1, and 2 years after index procedure	Yes