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

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.
 
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

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.


Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: Bifurcation stenting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
Study Start Date : April 2012
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: 2-link stent Nobori
Bifurcation stenting
Device: Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience

Active Comparator: 3-link stent Xience
Bifurcation stenting
Device: Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience




Primary Outcome Measures :
  1. Minimum lumen diameter of the side branch ostium in bifurcation [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Incidence of MACE [ Time Frame: in-hospital, 30 days, 8 months, 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01574586


Locations
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Japan
Kurashiki Central Hospital
Kurashiki, Japan, 710-8602
Sponsors and Collaborators
Kurashiki Central Hospital
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Responsible Party: Kurashiki Central Hospital
ClinicalTrials.gov Identifier: NCT01574586    
Other Study ID Numbers: BEGIN12
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Kurashiki Central Hospital:
True Bifurcation stenosis
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases