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

NCT ID: NCT01873027

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 829 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-07-31

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OFDI

Intervention Type: DEVICE

• 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

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.

Group Type: ACTIVE_COMPARATOR

IVUS

Intervention Type: DEVICE

• 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

LUNAWAVE; Fastview; Biolimus a9-eluting stent (Nobori stent); VISIWAVE; ViewIT; Biolimus A9-eluting stent (Nobori stent)

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wakayama Medical University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takashi Akasaka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wakayama Medical University

Locations

Wakayama Medical University

Wakayama, Wakayama, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 29121226 (View on PubMed)

Other Identifiers

UMIN000010580

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRICVD1225

Identifier Type: -

Identifier Source: org_study_id