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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Shenyang Northern Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01418794
First received: August 16, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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 Intervention Phase
Acute Coronary Syndromes
Device: High dose rapamycin stent
Device: Low dose rapamycin stent
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • 270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA) [ Time Frame: 270 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment [ Time Frame: 270 days ] [ Designated as safety issue: No ]
  • Composite end point of major adverse cardiac events(MACE) [ Time Frame: 30 days, 6 months, 9 months, 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours, 30 days and 1 year ] [ Designated as safety issue: Yes ]
    according to ARC definition

  • Success rate of stent implantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 606
Study Start Date: October 2010
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418794

Contacts
Contact: Ya-Ling Han, MD +86-24-23922184 hanyaling.nh@gmail.com
Contact: Yi Li, MD +86-24-23991876 doctorliyi@126.com

Locations
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Bo Yu, MD    +86-451-86605346    yubodr@163.com   
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: Chuan-Yu Gao, MD    +86-371-65580011    Gaocy2000@yahoo.com.cn   
China, Liaoning
Shenyang Northern Hospital Recruiting
Shenyang, Liaoning, China, 110016
Contact: Yi Li, MD    +86-24-28851168    doctorliyi@126.com   
China, Tianjin
Armed Police Force Medical College Hospital Recruiting
Tianjin, Tianjin, China, 300162
Contact: Tie-Min Jiang, MD    +86-22-60578777    wjyxyfy@126.com   
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Ya-Ling Han, MD Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Yaling Han, M.D. PhD, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01418794     History of Changes
Other Study ID Numbers: SYNH-20101010
Study First Received: August 16, 2011
Last Updated: August 16, 2011
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
Acute Coronary Syndromes
Drug eluting stent
Diffused lesion

Additional relevant MeSH terms:
Coronary Artery Disease
Syndrome
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014