Coronary Artery Stenosis Clinical Trial
— REFIREOfficial 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
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.
Status | Withdrawn |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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Jiao Tong University School of Medicine |
China,
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 |
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