Status:
UNKNOWN
Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
Lead Sponsor:
Shenyang Northern Hospital
Conditions:
Acute Coronary Syndromes
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 resteno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT01418794
Start Date
October 1 2010
Last Update
August 17 2011
Active Locations (4)
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1
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
3
Shenyang Northern Hospital
Shenyang, Liaoning, China, 110016
4
Armed Police Force Medical College Hospital
Tianjin, Tianjin Municipality, China, 300162