Status:
COMPLETED
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Wakayama Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-85 years
Phase:
PHASE3
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 wit...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
829 Patients enrolled
Trial Details
Trial ID
NCT01873027
Start Date
June 1 2013
End Date
July 1 2016
Last Update
July 14 2016
Active Locations (1)
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1
Wakayama Medical University
Wakayama, Wakayama, Japan, 641-8510