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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
606
Concentration of rapamycin is 2.5%
Concentration of rapamycin is 1.5%
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGShenyang Northern Hospital
Shenyang, Liaoning, China
RECRUITING270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
Time frame: 270 days
Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Time frame: 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
Time frame: 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
Time frame: 24 hours, 30 days and 1 year
Success rate of stent implantation
Time frame: 1 year
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Armed Police Force Medical College Hospital
Tianjin, Tianjin Municipality, China
RECRUITING