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the Cypher SES is now withdrawing in China market
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Firebird 2 stent group | Experimental | patients who were implated with Firebird 2 SES |
|
| Cypher Stent Group | Active Comparator | patients who were implanted with Cypher SES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firebird 2 SES | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Cypher SES | Device | The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating. |
|
| D014652 |
| Vascular Diseases |