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Xience/Promus for Long Coronary Lesion Registry (XILLION)

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ClinicalTrials.gov Identifier: NCT01147237
Recruitment Status : Unknown
Verified June 2010 by Society for Advancement of Coronary Intervention Research.
Recruitment status was:  Enrolling by invitation
First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Society for Advancement of Coronary Intervention Research

Tracking Information
First Submitted Date  ICMJE June 17, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date June 22, 2010
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
Target lesion revascularization rate [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
  • Technical success [ Time Frame: Initial ]
  • Angiographic restenosis [ Time Frame: 9 months ]
  • Target vessel revascularization [ Time Frame: 1 year ]
  • Target lesion revascularization [ Time Frame: 2 year ]
  • Target vessel revascularization [ Time Frame: 2 year ]
  • Incidences of acute, sub acute, and late stent thrombosis [ Time Frame: 2 year ]
  • Incidence of MACCE [ Time Frame: 2 year ]
    defined as cardiac death, nonfatal acute myocardial infarction and cerebrovascular events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xience/Promus for Long Coronary Lesion Registry
Official Title  ICMJE A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease
Brief Summary The utilization of everolimus-eluting coronary stents in a coronary artery diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Long Coronary Artery Disease
Intervention  ICMJE Device: Intracoronary stent implantation
Everolimus-eluting stent implantation in patients with long coronary artery disease
Study Arms  ICMJE Experimental: Single arm study
Intervention: Device: Intracoronary stent implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 17, 2010)
450
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥20 years and are able to undergo CABG
  2. Females who are not pregnant
  3. Patients who present with angina symptoms or myocardial ischemia
  4. Patients available for post-procedural observation and coronary angiography at 24 months
  5. Patients who have signed patient informed consent
  6. Lesion length is more than 30mm
  7. De novo lesion or non-stented restenosed lesion

Exclusion Criteria:

  1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
  2. Patients with significant allergic reaction to contrast medium
  3. Chronic total occlusion
  4. Lesion with TIMI0
  5. Patients with chronic renal failure (SCr>3.0mg/dl) -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01147237
Other Study ID Numbers  ICMJE XILLION
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenya Nasu, Toyohashi Heart Center
Study Sponsor  ICMJE Society for Advancement of Coronary Intervention Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuji Oikawa, MD, PhD Cardiovascular institute hospital
Principal Investigator: Kenya Nasu, MD Toyohashi Heart Center
PRS Account Society for Advancement of Coronary Intervention Research
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP