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

April 6, 2015 updated by: Kurashiki Central Hospital

A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

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

  • Japan
      • Kurashiki, Japan, 710-8602
        • Kurashiki Central Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Minimum lumen diameter of the side branch ostium in bifurcation
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of MACE
Time Frame: in-hospital, 30 days, 8 months, 1 year
in-hospital, 30 days, 8 months, 1 year

Collaborators and Investigators

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

Sponsor

Kurashiki Central 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

April 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEGIN12

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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