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

Phase 4

• Conditions: Acute Coronary Syndromes
• Interventions: Device: Low dose rapamycin stent; Device: High dose rapamycin stent

• Registration Number: NCT01418794
• Lead Sponsor: Shenyang Northern Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Last Update Submitted: 2011-08-16
• Study First Posted: 2011-08-17
• Last Update Posted: 2011-08-17
• Primary Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 606

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose rapamycin group	Low dose rapamycin stent	Concentration of rapamycin was 1.5%
High dose rapamycin group	High dose rapamycin stent	Concentration of rapamycin is 2.5%

Primary Outcome Measures

Name	Time	Method
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)	270 days

Secondary Outcome Measures

Name	Time	Method
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)	30 days, 6 months, 9 months, 1 year	Composite end point of cardiac death, all Q-wave and non-Q wave myocardial infarction, clinical-driven target lesion revascularisation
Stent thrombosis events after PCI for 24 hours, 30 days and 1 year	24 hours, 30 days and 1 year	according to ARC definition
Success rate of stent implantation	1 year

Trial Locations

Locations (4)

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Armed Police Force Medical College Hospital; 🇨🇳 Tianjin, Tianjin, China

Shenyang Northern Hospital; 🇨🇳 Shenyang, Liaoning, China

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China