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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Division of Biometrics,National Center for Cardiovascular Diseases,China | UNKNOWN |
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A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOYA | Experimental | implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent |
|
| Firebird2 | Active Comparator | implant Firebird2 drug-eluting stents Intervention: Device: stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent | Device | NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd. Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late loss at 9-month | Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. | 270 days (±30days) |
| Measure | Description | Time Frame |
|---|---|---|
| MACEs found in follow-up period | Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, Professor | Fu Wai Hospital, National Center for Cardiovascular Diseases,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23171800 | Derived | Xu B, Dou K, Yang Y, Lv S, Wang L, Wang H, Li Z, Wang L, Chen Y, Huo Y, Li W, Kirtane AJ, Gao R. Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial. EuroIntervention. 2012 Nov 22;8(7):796-802. doi: 10.4244/EIJV8I7A122. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |