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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001814
Receipt No. R000002181
Scientific Title Routine use of debris aspiration before retrieval of filter protection devices in carotid arterial stenting: Analysis of debris captured by filter device and aspiration
Date of disclosure of the study information 2009/04/01
Last modified on 2013/04/08

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Basic information
Public title Routine use of debris aspiration before retrieval of filter protection devices in carotid arterial stenting: Analysis of debris captured by filter device and aspiration
Acronym Routine aspiration during CAS and debris analysis
Scientific Title Routine use of debris aspiration before retrieval of filter protection devices in carotid arterial stenting: Analysis of debris captured by filter device and aspiration
Scientific Title:Acronym Routine aspiration during CAS and debris analysis
Region
Japan

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

Objectives
Narrative objectives1 We will clarify an effectiveness of routine use of debris aspiration before retrieval of filter protection devices in carotid arterial stenting.
Then, we will examine the debris captured by filter device and aspiration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number and size of aspirated debris.
Neurological status one month after the procedure.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We will aspirate debris and blood routinely before retrieval of filter protection devices.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with carotid artery stenosis of 60% and more in symptomatic stenosis, and 80% and more in asymptomatic stenosis.
Key exclusion criteria Patients with previous severe disabling stroke.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Sorimachi
Organization Brain Research Institute, University of Niigata
Division name Department of Neurosurgery
Zip code
Address 1-757, Asahimachidori, Chuoku, Niigata
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Sorimachi
Organization Brain Research Institute, University of Niigata
Division name Department of Neurosurgery
Zip code
Address
TEL
Homepage URL
Email sorimachi@bri.niigata-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Brain Research Institute, University of Niigata
Institute
Department

Funding Source
Organization Department of Neurosurgery, Brain Research Institute, University of Niigata
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
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The captured debris appeared to originate from atheromatous plaques. If the routine aspiration method had not been used in the present series, the debris might have migrated into intracerebral arteries. Restriction of the extension of a proximal ICA angulation might reduce the amount of debris associated with CAS, especially when the proximal ICA angulation is pronounced.
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 Completed
Date of protocol fixation
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 08 Day
Date trial data considered complete
2013 Year 04 Month 08 Day
Date analysis concluded
2013 Year 04 Month 08 Day

Other
Other related information The results were published in an article "Routine aspiration method during filter-protected carotid stenting: histological evaluation of captured debris and predictors for debris amount. Sorimachi T, Kakita A, Morita K, Nishino K, Sasaki O, Koike T, Kumagai T, Ito Y, Fujii Y. Acta Neurochir (Wien). 2011 Nov;153(11):2159-67."

Management information
Registered date
2009 Year 03 Month 30 Day
Last modified on
2013 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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