Clinical trial NCT01873027: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
Official title: OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention
Optical Frequency Domain Imaging
Intravascular Ultrasound
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Wakayama Medical University
First posted: 2013-06-07
Enrollment: 829
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months after PCI
Secondary outcomes:
measure: Cardiac death
timeFrame: 12 months after PCI
measure: Myocardial Infarction (MI)
timeFrame: 12 months after PCI
measure: Clinically-driven Target lesion revascularization (TLR)
timeFrame: 12 months after PCI
measure: MACE (composite of cardiac death, MI, TLR)
timeFrame: 12 months after PCI
measure: Target Vessel Revascularization (TVR)
timeFrame: 12 months after PCI
measure: Stroke
timeFrame: 12 months after PCI
measure: Stent thrombosis
timeFrame: 12 months after PCI
measure: Binary restenosis
timeFrame: 12 months after PCI
measure: Renal dysfunction
timeFrame: 8 months after PCI
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
state: Wakayama Prefecture
Study officials:
affiliation: Wakayama Medical University
name: Takashi Akasaka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.