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Using 3D Imaging to Optimize Bifurcation Stenting

NCT02972489 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2016-11-23

No results posted yet for this study

Summary

The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.

Conditions

Interventions

DEVICE

3D OFDI guidance arm

Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.

DEVICE

Angio guidance arm

In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.

Sponsors & Collaborators

  • Fujita Health University

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Terumo Corporation

    collaborator INDUSTRY

  • Increase Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yoshinobu Onuma · Fujita Health University/Erasmus University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Japan
  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02972489 on ClinicalTrials.gov