UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021050 |
|---|---|
| Receipt number | R000024278 |
| Scientific Title | Study of safety and efficay of preoperative intercostal and lumbar artery embolization for prevention of paraplegia in the treatment of thoracic and thoracoabdominal aortic pathology |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2016/04/08 17:32:46 |
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Basic information
Public title
Study of safety and efficay of preoperative intercostal and lumbar artery embolization for prevention of paraplegia in the treatment of thoracic and thoracoabdominal aortic pathology
Acronym
Preoperative intercostal and lumbar aretery embolization for prevention of paraplegia in aortic repair
Scientific Title
Study of safety and efficay of preoperative intercostal and lumbar artery embolization for prevention of paraplegia in the treatment of thoracic and thoracoabdominal aortic pathology
Scientific Title:Acronym
Preoperative intercostal and lumbar aretery embolization for prevention of paraplegia in aortic repair
Region
| Japan |
Condition
Condition
Aortic aneurysm and dessection in distal aortic arch, descending aorta, and thoraciabdomonal aorta
Classification by specialty
| Vascular surgery | Radiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of preoperative intercostal and lumbar artery coil embolization in prevantion of posoperative paraplegia in the treatment of thoracic and thoracoabdominal aortic pathology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Incidence of spinal cord injury after aortic operation at discharge
Key secondary outcomes
Incidence and severity of spinal cord injury after coil emblization.
Complications after coil embolization.
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
Coil embolization of intercostal and lummbar arteries.
2 weeks or more before the aortic operation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients indicated for surgery for aortic aneurysm or aortic dissection.
Patients with distal arch, descending, or thoracoabdominal arotic aneurym or aortic diessection, who are deemed high risk for spinal cord injury.
Key exclusion criteria
Emergent operation
Shaggy aorta
Previous spinal cord injury
Patients unfit for aortic surgery
Patients unsuitable for coil embolization
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shibata Toshihiko |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
81-6-6645-3980
shibata-cvs@zeus.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shibata Toshihiko |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
81-6-6645-3980
Homepage URL
shibata-cvs@zeus.eonet.ne.jp
Sponsor or person
Institute
Osaka City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. of Cardiovascular Surgery, Osaka City University Graduate School of Medicine
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
大阪市立大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2016 | 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=R000024278
