UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001814 |
|---|---|
| Receipt number | 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 15:12:30 |
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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
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
sorimachi@bri.niigata-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Brain Research Institute, University of Niigata
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
