- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01873222
OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Wakayama Prefecture
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Wakayama, Wakayama Prefecture, Japan, 641-8510
- Wakayama Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OFDI-guided PCI & IVUS
|
Other Names:
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Active Comparator: IVUS-guided PCI & OFDI
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimum stent area by OFDI
Time Frame: at just after the PCI
|
The investigators will assess "Minimum stent area" by OFDI at post-PCI.
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at just after the PCI
|
Frequency of malapposed struts
Time Frame: at just after the PCI
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The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.
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at just after the PCI
|
Dissection
Time Frame: at just after the PCI
|
The investigators will assess "Dissection" by OFDI at post-PCI.
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at just after the PCI
|
Minimum stent area by IVUS
Time Frame: at just after the PCI
|
The investigators will assess "Minimum stent area" by IVUS at post-PCI.
|
at just after the PCI
|
Frequency of uncovered struts
Time Frame: 8 months after PCI
|
The investigators will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.
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8 months after PCI
|
Minimum lumen area
Time Frame: 8-month follow-up after PCI
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The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.
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8-month follow-up after PCI
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Takashi Akasaka, MD, PhD, Wakayama Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
- Umirolimus
Other Study ID Numbers
- TRICVD1311
- UMIN000010581 (Registry Identifier: UMIN Clinical Trial Registry)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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