UMIN-CTR Clinical Trial

Basic information
Public title	Observation of cervical arteriosclerotic lesions by optical coherence tomography
Acronym	Observation of cervical arteriosclerotic lesions by optical coherence tomography
Scientific Title	Visualization of vascular cross section by application of optical coherence tomography in carotid endarterectomy
Scientific Title:Acronym	Visualization of vascular cross section by application of optical coherence tomography in carotid endarterectomy
Region	Japan

Condition
Condition	Cervical carotid stenosis
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By applying the optical coherence tomography method used for in vivo evaluation of coronary arteries to carotid endarterectomy, detailed evaluation of carotid arteries and plaques (arteriosclerotic lesions) will be performed in vivo.
Basic objectives2	Others
Basic objectives -Others	To compare with the imaging and pathological findings by observing the cross section of the blood vessel before and after the lesion is removed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of findings of optical coherence tomography and pathological findings of atehlosclerosis.
Key secondary outcomes	Comparison of findings of optical coherence tomography and preoperative imaging findings of atehlosclerosis.

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient undergoing carotid endarterectomy
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Ichinose
Organization	Osaka City University
Division name	Neurosurgery
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	0666453846
Email	ichinose-t@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Tsutomu Middle name Last name Ichinose
Organization	Osaka City University
Division name	Neurosurgery
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	0666453846
Homepage URL
Email	ichinose-t@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Osaka City University Graduate School of Medicine
Address	1-4-3, Asahi-machi, Abeno-ku,Osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2021-205
Org. issuing International ID_1	Ethical Committee of Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 05 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	Preinitiation
Date of protocol fixation	2021 Year 12 Month 21 Day
Date of IRB	2021 Year 12 Month 28 Day
Anticipated trial start date	2022 Year 01 Month 05 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 01 Month 04 Day
Last modified on	2022 Year 01 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053095