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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873222
• Other study ID #: TRICVD1311
• Secondary ID: UMIN000010581
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2013
• Last updated: July 13, 2016
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee of Wakayama Medical University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• OFDI-guided PCI & IVUS
Assessment by IVUS at post-PCI Assessment by OFDI at a 8-month follow-up
• IVUS-guided PCI & OFDI
Assessment by OFDI at post-PCI Assessment by OFDI at a 8-month follow-up

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama	Wakayama Prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum stent area by OFDI	The investigators will assess "Minimum stent area" by OFDI at post-PCI.	at just after the PCI	No
Primary	Frequency of malapposed struts	The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.	at just after the PCI	No
Primary	Dissection	The investigators will assess "Dissection" by OFDI at post-PCI.	at just after the PCI	No
Primary	Minimum stent area by IVUS	The investigators will assess "Minimum stent area" by IVUS at post-PCI.	at just after the PCI	No
Primary	Frequency of uncovered struts	The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.	8 months after PCI	No
Primary	Minimum lumen area	The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.	8-month follow-up after PCI	No