OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
2 other identifiers
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 coronary-artery-disease
Started Jun 2013
Typical duration for phase_3 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 14, 2016
July 1, 2016
3.1 years
May 27, 2013
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Minimum stent area by OFDI
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
at just after the PCI
Frequency of malapposed struts
The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
at just after the PCI
Dissection
The investigators will assess "Dissection" by OFDI at post-PCI.
at just after the PCI
Minimum stent area by IVUS
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
at just after the PCI
Frequency of uncovered struts
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
8 months after PCI
Minimum lumen area
The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
8-month follow-up after PCI
Study Arms (2)
OFDI-guided PCI & IVUS
EXPERIMENTAL* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up
IVUS-guided PCI & OFDI
ACTIVE COMPARATOR* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up
Interventions
* Assessment by IVUS at post-PCI * Assessment by OFDI at a 8-month follow-up
* Assessment by OFDI at post-PCI * Assessment by OFDI at a 8-month follow-up
Eligibility Criteria
You may qualify if:
- Patients participating in the OPINION Trial
- Patients who has provided written informed consent
You may not qualify if:
- Ineligible patients according to the investigator's judgment
- Inability or unwillingness to perform required follow up procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wakayama Medical University
Wakayama, Wakayama, 641-8510, Japan
Related Publications (1)
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.
PMID: 28917678DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takashi Akasaka, MD, PhD
Wakayama Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
June 10, 2013
Study Start
June 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
July 14, 2016
Record last verified: 2016-07