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

Shenyang Northern Hospital

Status and phase: Unknown; Phase 4

Conditions: Acute Coronary Syndromes

Treatments: Device: Low dose rapamycin stent; Device: High dose rapamycin stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01418794

SYNH-20101010

Details and patient eligibility

About

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.

Enrollment: 606 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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606 participants in 2 patient groups

Low dose rapamycin group

Active Comparator group

Description:

Concentration of rapamycin was 1.5%

Treatment:

Device: Low dose rapamycin stent

High dose rapamycin group

Experimental group

Description:

Concentration of rapamycin is 2.5%

Treatment:

Device: High dose rapamycin stent