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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: OFDI-guided PCI & IVUS; Device: IVUS-guided PCI & OFDI

• Registration Number: NCT01873222
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Study Timeline

• Study First Submitted: 2013-05-27
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OFDI-guided PCI & IVUS	OFDI-guided PCI & IVUS	* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDI	IVUS-guided PCI & OFDI	* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up

Primary Outcome Measures

Name	Time	Method
Minimum stent area by OFDI	at just after the PCI	The investigators will assess "Minimum stent area" 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 malapposed struts	at just after the PCI	The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
Minimum lumen area	8-month follow-up after PCI	The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
Frequency of uncovered struts	8 months after PCI	The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.

Trial Locations

Locations (1)

Wakayama Medical University; 🇯🇵 Wakayama, Wakayama Prefecture, Japan