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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wakayama Medical University
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT01873222
First received: May 27, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: OFDI-guided PCI & IVUS
Device: IVUS-guided PCI & OFDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Frequency of malapposed struts [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
    We will assess "Frequency of malapposed struts" by OFDI at post-PCI.


Secondary Outcome Measures:
  • Minimum stent area [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
    We will assess "Minimum stent area" by IVUS at post-PCI.

  • Dissection [ Time Frame: post-PCI ] [ Designated as safety issue: No ]
    We will assess "Dissection" by OFDI at post-PCI.

  • Frequency of uncovered struts [ Time Frame: 8 months after PCI ] [ Designated as safety issue: No ]
    We will assess "Frequency of uncovered struts" by OFDI at 8 months after PCI.

  • Minimum lumen area [ Time Frame: 8-month follow-up after PCI ] [ Designated as safety issue: No ]
    We will assess "Minimum lumen area by OFDI at 8 months after PCI.


Enrollment: 106
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873222

Locations
Japan
Wakayama Medical University
Wakayama, Wakayama Prefecture, Japan, 641-8510
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Wakayama Medical University
Investigators
Principal Investigator: Takashi Akasaka, MD, PhD Wakayama Medical University
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01873222     History of Changes
Other Study ID Numbers: TRICVD1311, UMIN000010581
Study First Received: May 27, 2013
Last Updated: August 11, 2014
Health Authority: Japan: Ethics Committee of Wakayama Medical University

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Coronary Artery Disease
Percutaneous Coronary Intervention
Optical Frequency Domain Imaging
Intravascular Ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 01, 2015