NCT01873222

OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

Detailed description

Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment. This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy. We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI. We will then assess lesions by OFDI at a 8-month follo-up.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	OFDI-guided PCI & IVUS	* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up
DEVICE	IVUS-guided PCI & OFDI	* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2013-06-10
• Last updated: 2016-07-14

Locations

1 site across 1 country: Japan