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

August 16, 2011 updated by: Shenyang Northern Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

606

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • Shenyang Northern Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300162
        • Recruiting
        • Armed Police Force Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
270-day(+60 days) in-stent late lumen loss(LLL) measured by quantitative coronary angiography (QCA)
Time Frame: 270 days
270 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restenosis rate in Stent, stent proximal edge, distal edge of stent and the lesion segment
Time Frame: 270 days
270 days
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
30 days, 6 months, 9 months, 1 year
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
24 hours, 30 days and 1 year
Success rate of stent implantation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

  • Principal Investigator: Ya-Ling Han, MD, Shenyang Northern Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNH-20101010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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