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

Primary Purpose

Coronary Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Bifurcation stenting
Sponsored by
Kurashiki Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis focused on measuring True Bifurcation stenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kurashiki Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2-link stent Nobori

3-link stent Xience

Arm Description

Bifurcation stenting

Bifurcation stenting

Outcomes

Primary Outcome Measures

Minimum lumen diameter of the side branch ostium in bifurcation

Secondary Outcome Measures

Incidence of MACE

Full Information

First Posted
April 6, 2012
Last Updated
April 6, 2015
Sponsor
Kurashiki Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01574586
Brief Title
Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
Acronym
BEGIN
Official Title
A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kurashiki Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
Keywords
True Bifurcation stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-link stent Nobori
Arm Type
Active Comparator
Arm Description
Bifurcation stenting
Arm Title
3-link stent Xience
Arm Type
Active Comparator
Arm Description
Bifurcation stenting
Intervention Type
Device
Intervention Name(s)
Bifurcation stenting
Intervention Description
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
Primary Outcome Measure Information:
Title
Minimum lumen diameter of the side branch ostium in bifurcation
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Incidence of MACE
Time Frame
in-hospital, 30 days, 8 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient eligible for percutaneous coronary intervention Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%) Second vessel at coronary bifurcation treatable with trial device during the procedure 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, Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch Target lesion treatable with one or two stents in both the main and side branches Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches Exclusion Criteria: A. General restrictions Unable to be followed by the implementing medial institution Life expectancy <1 year Acute myocardial infarction (<1 week) Left ventricular ejection fraction <30% Scheduled for elective treatment requiring antiplatelet drug Withdrawal Deemed as unsuitable by the investigator or subinvestigator Serum creatinine level ≥2.0 Mg/dl B. Vascular morphological restrictions Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting In-stent restenosis Severe calcification
Facility Information:
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan

12. IPD Sharing Statement

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Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience

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