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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014454
Receipt No. R000016619
Scientific Title Evaluation of "SPIDER FX" and "PROTEGE RX" for Carotid Artery Stenting (ESPER-CAS)
Date of disclosure of the study information 2014/07/02
Last modified on 2014/07/04

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Basic information
Public title Evaluation of "SPIDER FX" and "PROTEGE RX" for Carotid Artery Stenting (ESPER-CAS)
Acronym ESPER-CAS
Scientific Title Evaluation of "SPIDER FX" and "PROTEGE RX" for Carotid Artery Stenting (ESPER-CAS)
Scientific Title:Acronym ESPER-CAS
Region
Japan

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

Objectives
Narrative objectives1 To assess the safety and efficacy of the "PROTEGE RX Carotid Stent System" and the "SPIDER FX Embolic Protection Device" used in carotid artery stenting in routine clinical practice under coverage of general health insurance.
To determine the occurrence of adverse events and device malfunctions and identify factors involved in their occurrence, in order to further promote the proper use of the products.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes All stroke, myocardial infarction, and death within 30 days of the stenting procedure
Key secondary outcomes Adverse events
Ipsilateral ischemic stroke
Technical success and patency
Number of new ipsilateral ischemic lesions on MRI after the procedure (First imaging obtained 6 hours to 7 days after the stenting procedure)

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 To be included in this study, patients must be planned to undergo carotid artery stenting under coverage of general health insurance.
Key exclusion criteria Patients will be excluded if they have any contraindication as per the package insert for the PROTETE RX Carotid Stent System or the SPIDER FX Embolic Protection Device. The products must be used only under coverage of health insurance.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Nakahara
Organization Kokura Memorial Hospital
Division name Department of Neurosurgery
Zip code
Address 3-2-1 Asano, Kokurakita-ku, Kita-kyushu
TEL 093-511-2000
Email ichiro@mub.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Ohta
Organization Kokura Memorial Hospital
Division name Department of Neurosurgery
Zip code
Address 3-2-1 Asano, Kokurakita-ku, Kita-kyushu
TEL 093-511-2000
Homepage URL
Email espercas100@gmail.com

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization Covidien Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
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 順天堂大学医学部附属順天堂医院(東京都)
国立病院機構豊橋医療センター(愛知県)
国立循環器病研究センター病院(大阪府)
医真会八尾総合病院(大阪府)
国立病院機構九州医療センター(福岡県)
和歌山ろうさい病院(和歌山県)
藤田保健衛生大学(愛知県)
福岡大学病院(福岡県)
久留米大学(福岡県)
済生会和歌山病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 02 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Confirm that each patient meets all the inclusion criteria and does not meet any of the exclusion criteria. Obtain the patient's written informed consent to participate in the study before starting the study procedure. During the study period, patients will be enrolled consecutively until the predetermined sample size is achieved. Enrolling patients already treated with the study procedure is prohibited without exception. If the eligibility criteria checklist is not completed, enrollment will not be accepted until all the criteria are met.

This is an observational study of the use of the study devices in routine CAS procedure covered by the National Health Insurance, without any additional observation or examination other than in clinical practice. All the observations and examinations will be performed according to the Standard Operating Procedures of each study site.

Management information
Registered date
2014 Year 07 Month 02 Day
Last modified on
2014 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016619

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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