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Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience (BEGIN)

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ClinicalTrials.gov Identifier: NCT01574586
Recruitment Status : Unknown
Verified April 2015 by Kurashiki Central Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Kurashiki Central Hospital

Tracking Information
First Submitted Date  ICMJE April 6, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date April 7, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
Minimum lumen diameter of the side branch ostium in bifurcation [ Time Frame: 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
Incidence of MACE [ Time Frame: in-hospital, 30 days, 8 months, 1 year ]
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 Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
Official Title  ICMJE A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
Brief Summary

The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.

The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Stenosis
Intervention  ICMJE Device: Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
Study Arms  ICMJE
  • Active Comparator: 2-link stent Nobori
    Bifurcation stenting
    Intervention: Device: Bifurcation stenting
  • Active Comparator: 3-link stent Xience
    Bifurcation stenting
    Intervention: Device: Bifurcation stenting
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
Estimated Enrollment  ICMJE
 (submitted: April 6, 2012)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient eligible for percutaneous coronary intervention
  2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
  3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
  4. Second vessel at coronary bifurcation treatable with trial device during the procedure
  5. True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
  6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
  7. Target lesion treatable with one or two stents in both the main and side branches
  8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
  9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches

Exclusion Criteria:

A. General restrictions

  1. Unable to be followed by the implementing medial institution
  2. Life expectancy <1 year
  3. Acute myocardial infarction (<1 week)
  4. Left ventricular ejection fraction <30%
  5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal
  6. Deemed as unsuitable by the investigator or subinvestigator
  7. Serum creatinine level ≥2.0 Mg/dl

B. Vascular morphological restrictions

  1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
  2. In-stent restenosis
  3. Severe calcification
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (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 NCT01574586
Other Study ID Numbers  ICMJE BEGIN12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kurashiki Central Hospital
Study Sponsor  ICMJE Kurashiki Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kurashiki Central Hospital
Verification Date April 2015

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