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

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:
NCT01873027
First received: May 26, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.


Condition Intervention Phase
Coronary Artery Disease
Device: OFDI
Device: IVUS
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
    The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)


Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI) [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Clinically-driven Target lesion revascularization (TLR) [ Time Frame: 12 months after PCI ] [ Designated as safety issue: No ]
  • MACE (composite of cardiac death, MI, TLR) [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 12 months after PCI ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Binary restenosis [ Time Frame: 12 months after PCI ] [ Designated as safety issue: No ]
  • Renal dysfunction [ Time Frame: 8 months after PCI ] [ Designated as safety issue: Yes ]

Enrollment: 829
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI-guided PCI
  • OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.
Device: OFDI
  • OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
Other Names:
  • LUNAWAVE
  • Fastview
  • Biolimus a9-eluting stent (Nobori stent)
Active Comparator: IVUS-guided PCI
  • IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.
Device: IVUS
  • IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
  • Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI
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.

The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.

We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.

Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines
  • Patients aged between 20 and 85 years old
  • Patients who has provided written informed consent

Exclusion Criteria:

  • Patients with Acute Myocardial Infarction (AMI) within 3 months
  • Patients with cardiogenic shock
  • Patients with chronic heart failure
  • Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
  • Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
  • Patients planned use of bare metal stent
  • Patients with 3-vessel diseases
  • Planned surgery within 1 year
  • Patient on dialysis
  • Target lesion such as:

    • Left main coronary artery
    • Aorto-Ostial lesion location within 3mm of the aorta junction
    • Chronic total occlusion
    • Small vessel (reference vessel diameter <2.5mm)
    • Coronary artery bypass graft
  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: NCT01873027

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: NCT01873027     History of Changes
Other Study ID Numbers: TRICVD1225, UMIN000010580
Study First Received: May 26, 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014