Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Percutaneous Coronary Intervention, Optical Frequency Domain Imaging, Intravascular Ultrasound
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.
Interventions
DEVICEOFDI
* 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
DEVICEIVUS
* 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
Sponsors
Wakayama Medical University
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Cardiac death | 12 months after PCI |
| Stent thrombosis | 12 months after PCI |
| Binary restenosis | 12 months after PCI |
| Renal dysfunction | 8 months after PCI |
| Stroke | 12 months after PCI |
Countries
Japan
Outcome results
None listed