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

Acute Coronary Syndromes Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418794
• Other study ID #: SYNH-20101010
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2011
• Last updated: August 16, 2011
• Start date: October 2010

Study information

• Verified date: October 2010
• Source: Shenyang Northern Hospital
• Contact: Ya-Ling Han, MD
• Phone: +86-24-23922184
• Email: hanyaling.nh[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 606
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

Device:
• High dose rapamycin stent
Concentration of rapamycin is 2.5%
• Low dose rapamycin stent
Concentration of rapamycin is 1.5%

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shenyang Northern Hospital	Shenyang	Liaoning
China	Armed Police Force Medical College Hospital	Tianjin	Tianjin
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)		270 days	No
Secondary	Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment		270 days	No
Secondary	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	Yes
Secondary	Stent thrombosis events after PCI for 24 hours, 30 days and 1 year	according to ARC definition	24 hours, 30 days and 1 year	Yes
Secondary	Success rate of stent implantation		1 year	No