Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
NCT ID: NCT01418794
Last Updated: 2011-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
606 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low dose rapamycin group
Concentration of rapamycin was 1.5%
Low dose rapamycin stent
Concentration of rapamycin is 1.5%
High dose rapamycin group
Concentration of rapamycin is 2.5%
High dose rapamycin stent
Concentration of rapamycin is 2.5%
Interventions
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High dose rapamycin stent
Concentration of rapamycin is 2.5%
Low dose rapamycin stent
Concentration of rapamycin is 1.5%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Shenyang Northern Hospital
OTHER
Responsible Party
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Shenyang Northern Hospital
Principal Investigators
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Ya-Ling Han, MD
Role: PRINCIPAL_INVESTIGATOR
Shenyang Northern Hospital
Locations
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The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Shenyang Northern Hospital
Shenyang, Liaoning, China
Armed Police Force Medical College Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYNH-20101010
Identifier Type: -
Identifier Source: org_study_id
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