NCT01873027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
829

participants targeted

Target at P75+ for phase_3 coronary-artery-disease

Timeline
Completed

Started Jun 2013

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

3.1 years

First QC Date

May 26, 2013

Last Update Submit

July 13, 2016

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseasePercutaneous Coronary InterventionOptical Frequency Domain ImagingIntravascular Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Failure (TVF)

    The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)

    12 months after PCI

Secondary Outcomes (9)

  • Cardiac death

    12 months after PCI

  • Myocardial Infarction (MI)

    12 months after PCI

  • Clinically-driven Target lesion revascularization (TLR)

    12 months after PCI

  • MACE (composite of cardiac death, MI, TLR)

    12 months after PCI

  • Target Vessel Revascularization (TVR)

    12 months after PCI

  • +4 more secondary outcomes

Study Arms (2)

OFDI-guided PCI

EXPERIMENTAL

* 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

IVUS-guided PCI

ACTIVE COMPARATOR

* 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

Interventions

OFDIDEVICE

* 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

Also known as: LUNAWAVE, Fastview, Biolimus a9-eluting stent (Nobori stent)
OFDI-guided PCI
IVUSDEVICE

* 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

Also known as: VISIWAVE, ViewIT, Biolimus A9-eluting stent (Nobori stent)
IVUS-guided PCI

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wakayama Medical University

Wakayama, Wakayama, 641-8510, Japan

Location

Related Publications (1)

  • Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.

    PMID: 29121226DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Takashi Akasaka, MD, PhD

    Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2013

First Posted

June 7, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

JP(1)