UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002808
Receipt number R000003306
Scientific Title Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT)
Date of disclosure of the study information 2009/11/27
Last modified on 2009/11/27 23:09:04

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Basic information

Public title

Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT)

Acronym

Carotid plaque imaging using OCT

Scientific Title

Clinical study regarding carotid plaque imaging using optical coherence tomography (OCT)

Scientific Title:Acronym

Carotid plaque imaging using OCT

Region

Japan


Condition

Condition

carotid artery stenosis

Classification by specialty

Cardiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Optical coherence tomography (OCT) was developed recently, and reported to have better resolving power than intravascular ultrasound. The aim of this study is to know the safety and efficacy of plaque imaging using OCT during carotid artery stenting.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Successful plaque imaging using OCT

Key secondary outcomes

Neurological event during OCT imaging


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patient who receives carotid artery stenting using proximal protection method

Key exclusion criteria

The patient who shows ischemic symptom during carotid artery occlusion

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Yoshimura

Organization

Graduate School of Medicine, Gifu University

Division name

Department of Neurosurgery

Zip code


Address

1-1 Yanagido, Gifu city, Gifu, Japan

TEL

+81-58-230-6271

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Yoshimura

Organization

Graduate School of Medicine, Gifu University

Division name

Department of Neurosurgery

Zip code


Address

1-1 Yanagido, Gifu city, Gifu, Japan

TEL

+81-58-230-6271

Homepage URL


Email

s-yoshi@gifu-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, Gifu University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

岐阜大学医学部附属病院(岐阜市)


Other administrative information

Date of disclosure of the study information

2009 Year 11 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2009 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2012 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Using intravascular OCT imaging system, plaque images are obtained during carotid artery stenting procedure. The findings of OCT imaging are compared with those of the other imaging systems such as IVUS.


Management information

Registered date

2009 Year 11 Month 27 Day

Last modified on

2009 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name