Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418794
Recruitment Status : Unknown
Verified October 2010 by Shenyang Northern Hospital.
Recruitment status was:  Recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Device: High dose rapamycin stent Device: Low dose rapamycin stent Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2010
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Low dose rapamycin group
Concentration of rapamycin was 1.5%
Device: Low dose rapamycin stent
Concentration of rapamycin is 1.5%

Experimental: High dose rapamycin group
Concentration of rapamycin is 2.5%
Device: High dose rapamycin stent
Concentration of rapamycin is 2.5%

Primary Outcome Measures :
  1. 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) [ Time Frame: 270 days ]

Secondary Outcome Measures :
  1. Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment [ Time Frame: 270 days ]
  2. Composite end point of major adverse cardiac events(MACE) [ Time Frame: 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

  3. Stent thrombosis events after PCI for 24 hours, 30 days and 1 year [ Time Frame: 24 hours, 30 days and 1 year ]
    according to ARC definition

  4. Success rate of stent implantation [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01418794

Layout table for location contacts
Contact: Ya-Ling Han, MD +86-24-23922184
Contact: Yi Li, MD +86-24-23991876

Layout table for location information
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Bo Yu, MD    +86-451-86605346   
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Chuan-Yu Gao, MD    +86-371-65580011   
China, Liaoning
Shenyang Northern Hospital Recruiting
Shenyang, Liaoning, China, 110016
Contact: Yi Li, MD    +86-24-28851168   
China, Tianjin
Armed Police Force Medical College Hospital Recruiting
Tianjin, Tianjin, China, 300162
Contact: Tie-Min Jiang, MD    +86-22-60578777   
Sponsors and Collaborators
Shenyang Northern Hospital
Layout table for investigator information
Principal Investigator: Ya-Ling Han, MD Shenyang Northern Hospital

Layout table for additonal information
Responsible Party: Yaling Han, M.D. PhD, Shenyang Northern Hospital Identifier: NCT01418794     History of Changes
Other Study ID Numbers: SYNH-20101010
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: August 17, 2011
Last Verified: October 2010
Keywords provided by Shenyang Northern Hospital:
Acute Coronary Syndromes
Drug eluting stent
Diffused lesion
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs