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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01873027 on ClinicalTrials.gov