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Polymer carried by drug-eluting stents may increase inflammatory response and thrombosis. Our previous study showed that polymer-free rapamycin-coated stents brings dose-dependent reduction in restenosis. This prospective, multicenter, randomized controlled clinical trials aimed to explore efficacy and safety of the YUKON drug eluting stent in diffuse coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose rapamycin group | Active Comparator | Concentration of rapamycin was 1.5% |
|
| High dose rapamycin group | Experimental | Concentration of rapamycin is 2.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose rapamycin stent | Device | Concentration of rapamycin is 2.5% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) | 270 days |
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment | 270 days | |
| Composite end point of major adverse cardiac events(MACE) | Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ya-Ling Han, MD | Contact | +86-24-23922184 | hanyaling.nh@gmail.com | |
| Yi Li, MD | Contact | +86-24-23991876 | doctorliyi@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ya-Ling Han, MD | Shenyang Northern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Low dose rapamycin stent |
| Device |
Concentration of rapamycin is 1.5% |
|
| 30 days, 6 months, 9 months, 1 year |
| Stent thrombosis events after PCI for 24 hours, 30 days and 1 year | according to ARC definition | 24 hours, 30 days and 1 year |
| Success rate of stent implantation | 1 year |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Shenyang Northern Hospital | Recruiting | Shenyang | Liaoning | 110016 | China |
|
| Armed Police Force Medical College Hospital | Recruiting | Tianjin | Tianjin Municipality | 300162 | China |
|