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NCT Number: NCT01873222

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wakayama Medical University

Wakayama, 641-8510, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OFDI-guided PCI & IVUS

Device
  • 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)

IVUS-guided PCI & OFDI

Device
  • 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)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Wakayama Medical University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2013
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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