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

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ClinicalTrials.gov Identifier: NCT01873222
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
Wakayama Medical University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: OFDI-guided PCI & IVUS Device: IVUS-guided PCI & OFDI Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging
Study Start Date : June 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OFDI-guided PCI & IVUS
  • Assessment by IVUS at post-PCI
  • Assessment by OFDI at a 8-month follow-up
 Device: OFDI-guided PCI & IVUS
  • Assessment by IVUS at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Other Names:
  • OFDI
  • LUNAWAVE
  • Biolimus A9-eluting stent (Nobori stent)
Active Comparator: IVUS-guided PCI & OFDI
  • Assessment by OFDI at post-PCI
  • Assessment by OFDI at a 8-month follow-up
 Device: IVUS-guided PCI & OFDI
  • Assessment by OFDI at post-PCI
  • Assessment by OFDI at a 8-month follow-up
Other Names:
  • VISIWAVE
  • ViewIT
  • Biolimus A9-eluting stent (Nobori stent)


Outcome Measures
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Primary Outcome Measures :
  1. Minimum stent area by OFDI [ Time Frame: at just after the PCI ]
    The investigators will assess "Minimum stent area" by OFDI at post-PCI.

  2. Frequency of malapposed struts [ Time Frame: at just after the PCI ]
    The investigators will assess "Frequency of malapposed struts" by OFDI at post-PCI.

  3. Dissection [ Time Frame: at just after the PCI ]
    The investigators will assess "Dissection" by OFDI at post-PCI.

  4. Minimum stent area by IVUS [ Time Frame: at just after the PCI ]
    The investigators will assess "Minimum stent area" by IVUS at post-PCI.

  5. 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.

  6. Minimum lumen area [ Time Frame: 8-month follow-up after PCI ]
    The investigators will assess "Minimum lumen area by OFDI at 8 months after PCI.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873222


Locations
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Japan
Wakayama Medical University
Wakayama, Wakayama Prefecture, Japan, 641-8510
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Wakayama Medical University
Investigators
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Principal Investigator: Takashi Akasaka, MD, PhD Wakayama Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01873222    
Other Study ID Numbers: TRICVD1311
UMIN000010581 ( Registry Identifier: UMIN Clinical Trial Registry )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Coronary Artery Disease
Percutaneous Coronary Intervention
Optical Frequency Domain Imaging
Intravascular Ultrasound
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Umirolimus
 Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents