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

Coronary Artery Disease Clinical Trial

— OPINION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873027
• Other study ID #: TRICVD1225
• Secondary ID: UMIN000010580
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2013
• Last updated: July 13, 2016
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee of Wakayama Medical University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama	Wakayama Prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cardiac death		12 months after PCI	Yes
Secondary	Myocardial Infarction (MI)		12 months after PCI	Yes
Secondary	Clinically-driven Target lesion revascularization (TLR)		12 months after PCI	No
Secondary	MACE (composite of cardiac death, MI, TLR)		12 months after PCI	Yes
Secondary	Target Vessel Revascularization (TVR)		12 months after PCI	No
Secondary	Stroke		12 months after PCI	Yes
Secondary	Stent thrombosis		12 months after PCI	Yes
Secondary	Binary restenosis		12 months after PCI	No
Secondary	Renal dysfunction		8 months after PCI	Yes