Using 3D Imaging to Optimize Bifurcation Stenting

PHASE4UnknownINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions
Coronary Artery DiseaseBifurcation Lesion
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.

Trial Locations (2)

470-1192

Fujita Health University, Toyoake

3015 CE

Erasmus University Medical Center, Rotterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Fujita Health University

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

Terumo Corporation

INDUSTRY

lead

Increase Co., Ltd.

INDUSTRY