UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059790 |
|---|---|
| Receipt number | R000068364 |
| Scientific Title | Efficacy of intraluminal shunt for preventing hyperperfusion following carotid endoarterectomy in patients with misery perfusion |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/11/15 16:39:38 |
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Basic information
Public title
Efficacy analysis of intraluminal shunt for preventing hyperperfusion following carotid endoarterectomy in patients with misery perfusion
Acronym
Efficacy of intraluminal shunt for preventing hyperperfusion following carotid endoarterectomy in patients with misery perfusion
Scientific Title
Efficacy of intraluminal shunt for preventing hyperperfusion following carotid endoarterectomy in patients with misery perfusion
Scientific Title:Acronym
Hyperperfusion prevention following CEA in patients with misery perfusion
Region
| Japan |
Condition
Condition
cervical carotid artery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if intraluminal shunt could prevent hyperperfusion following carotid endarterectomy in patients with misery perfusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hyperperfusion for up to 1-7 days after surgeries
Key secondary outcomes
Analysis of relation between findings of intraoperative monitoring and post-operative hyperperfusion
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
Apllication of intraluminal shunt during carotid endoarterectomy for patients with internal carotid artery stenosis
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 and Female
Key inclusion criteria
Patients who plan to undergo carotid endoarterectomy (CEA) and meet following criteria.
A)Patients who have misery perfusion on preoperative examinations and give consent.
B) Control group patients who had misery perfusion and underwent CEA without using intraluminal shunt between 2020/7/1 to 2025/6/30.
Key exclusion criteria
A)
1. Patients who have thinner diameter of outer diameter of intraluminal shunt tube (3mm)
2. Patients who lack required data.
B)
1. Patients who reject to be included the study
2. Patients that intraluminal shunt could not be implanted
3. Patients who lack required data.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Akamatsu |
Organization
Iwate Medical University Hospital
Division name
Department of Neurosurgery
Zip code
028-3694
Address
2-1-1, Idaidori, Yahaba
TEL
0196137111
akamatsu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Yanagihara |
Organization
Iwate Medical University Hospital
Division name
Neurosurgery
Zip code
028-3694
Address
2-1-1, Idaidori, Yahaba
TEL
0196137111
Homepage URL
akamatsu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Yosuke Akamatsu
Funding Source
Organization
None
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
Iwate Medical University Hospital
Address
2-1-1, Idaidori, Yahaba, Iwate, Japan, 028-3694
Tel
0196137111
syuhei.kadoguchi@j.iwate-med.ac.jp
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
| 2025 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068364
