Efficacy and Safety of the YUKON Drug Eluting Stent in Diffuse Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Device: High dose rapamycin stent
* Device: Low dose rapamycin stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose rapamycin group<br>Concentration of rapamycin was 1.5% | Device: Low dose rapamycin stent<br>* Concentration of rapamycin is 1.5%<br>|
| Experimental: High dose rapamycin group<br>Concentration of rapamycin is 2.5% | Device: High dose rapamycin stent<br>* Concentration of rapamycin is 2.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) |  | 270 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation | 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 | 24 hours, 30 days and 1 year | 
| Success rate of stent implantation |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndromes, Drug eluting stent, Diffused lesion