Unique ID issued by UMIN | UMIN000014454 |
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Receipt number | 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 | 2021/01/07 14:19:08 |
Evaluation of "SPIDER FX" and "PROTEGE RX" for Carotid Artery Stenting (ESPER-CAS)
ESPER-CAS
Evaluation of "SPIDER FX" and "PROTEGE RX" for Carotid Artery Stenting (ESPER-CAS)
ESPER-CAS
Japan |
carotid artery stenosis
Neurosurgery |
Others
NO
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.
Safety,Efficacy
Others
Pragmatic
Not applicable
All stroke, myocardial infarction, and death within 30 days of the stenting procedure
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)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
To be included in this study, patients must be planned to undergo carotid artery stenting under coverage of general health insurance.
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.
100
1st name | |
Middle name | |
Last name | Ichiro Nakahara |
Kokura Memorial Hospital
Department of Neurosurgery
3-2-1 Asano, Kokurakita-ku, Kita-kyushu
093-511-2000
ichiro@mub.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Tsuyoshi Ohta |
Kokura Memorial Hospital
Department of Neurosurgery
3-2-1 Asano, Kokurakita-ku, Kita-kyushu
093-511-2000
espercas100@gmail.com
Kokura Memorial Hospital
Covidien Japan Inc.
Profit organization
NO
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)
2014 | Year | 07 | Month | 02 | Day |
Unpublished
Terminated
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 07 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
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.
2014 | Year | 07 | Month | 02 | Day |
2021 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016619
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