UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shibata Toshihiko
Organization	Osaka City University Graduate School of Medicine
Division name	Dept. of Cardiovascular Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL	81-6-6645-3980
Email	shibata-cvs@zeus.eonet.ne.jp

Public contact
Name of contact person	Shibata Toshihiko
Organization	Osaka City University Graduate School of Medicine
Division name	Dept. of Cardiovascular Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL	81-6-6645-3980
Homepage URL
Email	shibata-cvs@zeus.eonet.ne.jp

Sponsor
Institute	Osaka City University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000024278