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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan106 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Coronary Artery Disease

Interventions

OFDI-guided PCI & IVUSDEVICE

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

IVUS-guided PCI & OFDIDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Wakayama Medical University

Wakayama, Wakayama, Japan

Outcomes

Primary Outcomes

Minimum stent area by OFDI

The investigators will assess "Minimum stent area" by OFDI at post-PCI.

Time frame: at just after the PCI

Frequency of malapposed struts

The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.

Time frame: at just after the PCI

Dissection

The investigators will assess "Dissection" by OFDI at post-PCI.

Time frame: at just after the PCI

Minimum stent area by IVUS

The investigators will assess "Minimum stent area" by IVUS at post-PCI.

Time frame: at just after the PCI

Frequency of uncovered struts

The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.

Time frame: 8 months after PCI

Minimum lumen area

The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.

Time frame: 8-month follow-up after PCI

Data from ClinicalTrials.gov

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