Acute Coronary Syndromes
Conditions
Keywords
Acute Coronary Syndromes, Drug eluting stent, Diffused lesion
Brief summary
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.
Interventions
DEVICEHigh dose rapamycin stent
Concentration of rapamycin is 2.5%
DEVICELow dose rapamycin stent
Concentration of rapamycin is 1.5%
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18-85 years old, male or nonpregnant women * asymptomatic ischemia, stable or unstable angina, old myocardial infarction patients * at least one target lesion length ≥ 20 mm (Visual method) * Target lesion diameter 2.5mm-4.0 mm (Visual method) * Target lesion diameter stenosis ≥ 70% * Patients who has indications for coronary artery bypass graft (CABG) surgery * Patients who is voluntary, understand the purpose of the study, willing to accept angiography and clinical follow-up
Exclusion criteria
* Acute myocardial infarction for less than 1 week * Bridge vascular disease * In-stent restenosis lesions * Patient with bleeding tendency, history of active peptic ulcer, History of cerebral hemorrhage or subarachnoid hemorrhage, history of stroke within half year, contraindications to anticoagulant therapy and antiplatelet * Allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast agent, rapamycin and metal * Life expectancy is less than 12 months * Patient who has participated in other clinical trials but does not meet the deadline of the primary endpoint * Poor patient compliance * Heart transplant recipient * Patient who had other stent implanted within 1 year * Patient who has multi-vessel disease(Long lesions) and has already received other stent implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) | 270 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 30 days, 6 months, 9 months, 1 year | Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation |
| Stent thrombosis events after PCI for 24 hours, 30 days and 1 year | 24 hours, 30 days and 1 year | according to ARC definition |
| Success rate of stent implantation | 1 year | — |
Countries
China
Contacts
Primary ContactYa-Ling Han, MD
Backup ContactYi Li, MD
Outcome results
None listed