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

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ClinicalTrials.gov Identifier: NCT01873027
Recruitment Status : Completed
First Posted : June 7, 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

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: OFDI Device: IVUS 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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
Study Start Date : June 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




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


Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 12 months after PCI ]
  2. Myocardial Infarction (MI) [ Time Frame: 12 months after PCI ]
  3. Clinically-driven Target lesion revascularization (TLR) [ Time Frame: 12 months after PCI ]
  4. MACE (composite of cardiac death, MI, TLR) [ Time Frame: 12 months after PCI ]
  5. Target Vessel Revascularization (TVR) [ Time Frame: 12 months after PCI ]
  6. Stroke [ Time Frame: 12 months after PCI ]
  7. Stent thrombosis [ Time Frame: 12 months after PCI ]
  8. Binary restenosis [ Time Frame: 12 months after PCI ]
  9. Renal dysfunction [ Time Frame: 8 months after PCI ]


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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 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

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): NCT01873027


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

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: NCT01873027     History of Changes
Other Study ID Numbers: TRICVD1225
UMIN000010580 ( Registry Identifier: UMIN Clinical Trials Registry )
First Posted: June 7, 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
Umirolimus
Sirolimus
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents