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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: OFDI; Device: IVUS

• Registration Number: NCT01873027
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-05-26
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 829

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFDI-guided PCI	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 12 months after PCI.
IVUS-guided 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 12 months after PCI.

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure (TVF)	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

Name	Time	Method
Stent thrombosis	12 months after PCI
Myocardial Infarction (MI)	12 months after PCI
MACE (composite of cardiac death, MI, TLR)	12 months after PCI
Cardiac death	12 months after PCI
Clinically-driven Target lesion revascularization (TLR)	12 months after PCI
Stroke	12 months after PCI
Target Vessel Revascularization (TVR)	12 months after PCI
Binary restenosis	12 months after PCI
Renal dysfunction	8 months after PCI

Trial Locations

Locations (1)

Wakayama Medical University; 🇯🇵 Wakayama, Wakayama Prefecture, Japan