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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: Firebird 2 SES
* Device: Cypher SES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firebird 2 stent group<br>patients who were implated with Firebird 2 SES | Device: Firebird 2 SES<br>* 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.<br>|
| Active Comparator: Cypher Stent Group<br>patients who were implanted with Cypher SES | Device: Cypher SES<br>* The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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significant stenosis (>70% of lumen stenosis), epicardial coronary arteries.