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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
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.
The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
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
Time frame: 9 months
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 \[PTCA\]).
Time frame: 1, and 2 years after index procedure
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