Clinical trial NCT01873222: OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Official title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention
Optical Frequency Domain Imaging
Intravascular Ultrasound
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Wakayama Medical University
First posted: 2013-06-10
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Minimum stent area by OFDI
timeFrame: at just after the PCI
measure: Frequency of malapposed struts
timeFrame: at just after the PCI
measure: Dissection
timeFrame: at just after the PCI
measure: Minimum stent area by IVUS
timeFrame: at just after the PCI
measure: Frequency of uncovered struts
timeFrame: 8 months after PCI
measure: Minimum lumen area
timeFrame: 8-month follow-up after PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
state: Wakayama Prefecture
Study officials:
affiliation: Wakayama Medical University
name: Takashi Akasaka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Otake H, Kubo T, Takahashi H, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Kozuma K, Ioji T, Kaneda H, Akasaka T; OPINION Investigators. Optical Frequency Domain Imaging Versus Intravascular Ultrasound in Percutaneous Coronary Intervention (OPINION Trial): Results From the OPINION Imaging Study. JACC Cardiovasc Imaging. 2018 Jan;11(1):111-123. doi: 10.1016/j.jcmg.2017.06.021. Epub 2017 Oct 5.