UMIN-CTR Clinical Trial

Basic information
Public title	Morphological evaluation of the carotid artery lumen after CASPER stent placement using OFDI
Acronym	Morphological evaluation after CASPER stent placement using OFDI
Scientific Title	Morphological evaluation of the carotid artery lumen after CASPER stent placement using OFDI
Scientific Title:Acronym	Morphological evaluation after CASPER stent placement using OFDI
Region	Japan

Condition
Condition	carotid artery stenosis
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to compare the rate and size of plaque protrusion between CASPER stent and conventional stents detected by OFDI and to evaluate the efficacy of CAS with CASPER stent for the cases with unstable plaque.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of plaque protrusion after CAS Presence of new ischemic lesion of the brain after CAS Neurological state at the 7days and 90days after CAS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	CASPER stent (Terumo, Tokyo)
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	85 years-old >=
Gender	Male
Key inclusion criteria	Patients who receive carotid artery stenting for the treatment of carotid artery stenosis. Symptomatic patients with 50% or more stenosis. Asymptomatic patients with 80% or more stenosis.
Key exclusion criteria	Patients who cannot receive carotid artery stenting
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Yoshimura
Organization	Hyogo College of Medicine
Division name	Neurosurgery
Zip code
Address	1-1 Mukogawacho Nishinomiya Hyogo
TEL	0798-45-6455
Email	shinichiyoshimura@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Kiyofumi Yamada
Organization	Hyogo College of Medicine
Division name	Neurosurgery
Zip code
Address	1-1 Mukogawacho Nishinomiya Hyogo
TEL	0798-45-6455
Homepage URL
Email	yamadakiyofumi@gmail.com

Sponsor
Institute	Department of Neurosurgery, Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Department of Neurosurgery
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 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	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 13 Day
Date of IRB	2015 Year 01 Month 13 Day
Anticipated trial start date	2015 Year 01 Month 13 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 05 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029387