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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: IVUS-guided PCI & OFDI; Device: OFDI-guided PCI & IVUS

Study type: Interventional

Funder types: Other

Identifiers

NCT01873222

UMIN000010581 (Registry Identifier)

TRICVD1311

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

OFDI-guided PCI & IVUS

Experimental group

Description:

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

Treatment:

Device: OFDI-guided PCI & IVUS

IVUS-guided PCI & OFDI

Active Comparator group

Description:

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

Treatment:

Device: IVUS-guided PCI & OFDI