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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873222

Enrollment

106

Registered

2013-06-10

Start date

2013-06-30

Completion date

2016-07-31

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound

Brief 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.

Interventions

DEVICEOFDI-guided PCI & IVUS

* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up

DEVICEIVUS-guided PCI & OFDI

* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients participating in the OPINION Trial * Patients who has provided written informed consent

Exclusion criteria

* Ineligible patients according to the investigator's judgment * Inability or unwillingness to perform required follow up procedures

Design outcomes

Primary

Measure	Time frame	Description
Minimum stent area by OFDI	at just after the PCI	The investigators will assess Minimum stent area by OFDI at post-PCI.
Frequency of malapposed struts	at just after the PCI	The investigators will assess Frequency of malapposed struts by OFDI at post-PCI.
Dissection	at just after the PCI	The investigators will assess Dissection by OFDI at post-PCI.
Minimum stent area by IVUS	at just after the PCI	The investigators will assess Minimum stent area by IVUS at post-PCI.
Frequency of uncovered struts	8 months after PCI	The investigators will assess Frequency of uncovered struts by OFDI at 8 months after PCI.
Minimum lumen area	8-month follow-up after PCI	The investigators will assess Minimum lumen area by OFDI at 8 months after PCI.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026