Clinical trial NCT01418794: Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes
Drug eluting stent
Diffused lesion
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
timeFrame: 270 days
Secondary outcomes:
measure: Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
timeFrame: 270 days
measure: Composite end point of major adverse cardiac events(MACE)
timeFrame: 30 days, 6 months, 9 months, 1 year
measure: Stent thrombosis events after PCI for 24 hours, 30 days and 1 year
timeFrame: 24 hours, 30 days and 1 year
measure: Success rate of stent implantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Shenyang
country: China
facility: Shenyang Northern Hospital
state: Liaoning
city: Tianjin
country: China
facility: Armed Police Force Medical College Hospital
state: Tianjin
Study officials:
affiliation: Shenyang Northern Hospital
name: Ya-Ling Han, MD
role: PRINCIPAL_INVESTIGATOR
References: