OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
NCT01873027 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 829
Last updated 2016-07-14
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.
Conditions
Interventions
- 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
- DEVICE
-
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
Sponsors & Collaborators
-
Wakayama Medical University
collaborator OTHER -
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
lead OTHER
Principal Investigators
-
Takashi Akasaka, MD, PhD · Wakayama Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
Countries
- Japan
Study Locations
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