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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031059
Receipt No. R000035441
Scientific Title The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Excluder stent-graft:multicenter prospective study
Date of disclosure of the study information 2018/03/01
Last modified on 2018/04/17

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Basic information
Public title The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Excluder stent-graft:multicenter prospective study
Acronym TAE for IMA and LA prior to EVAR(Excluder)study
Scientific Title The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Excluder stent-graft:multicenter prospective study
Scientific Title:Acronym TAE for IMA and LA prior to EVAR(Excluder)study
Region
Japan

Condition
Condition Abdominal aortic aneurysm
Classification by specialty
Vascular surgery Radiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak(EL2) prior to endovascular abdominal aortic aneurysm repair (EVAR) with Excluder stent-graft: multicenter prospective study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes The incidence of EL2 after EVAR in 6 months
Key secondary outcomes The incidence of EL2 after EVAR in 1 year
Technical success rate of IMA/LA embolization
Safety of IMA/LA embolization
Aneurysm diameter after EVAR within 30days, 6 month and 1 year
Aneurysm related death after EVAR within 30days, 6 month and 1 year
Re-intervention rate for EL2 after EVAR within 30days, 6 month and 1 year

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
Device,equipment Maneuver
Interventions/Control_1 Trans-catheter embolization for inferior mesenteric artery and lumbar artery with metalic coil prior to EVAR with Excluder stent-graft
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 The formation of abdominal aortic aneurysm is within the instruction for use (IFU) of Excluder stent-graft system.
The patients who is out of indication for open surgical repair, or refuse open surgical repair.
The patients who have sufficient renal function (eGFR above 45)
The patent branch vessels originated from aneurysm is at least above one confirmed with preoperative CT image.
ECOG performance status is 0 or 1.
Key exclusion criteria Rupture case
The severe stenosis or occlusion of superior mesenteric artery
The bilateral occlusion of internal iliac artery
Accessory renal artery exist in the range of stent-graft placement.
Uncontrollable of heart failure, angina pectoris, and arrhythmia despite of treatment
Concomitant with active cancer
Sever drug allergy
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Yamaguchi
Organization Kobe University Hospital
Division name Department of Radiology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6104
Email masato03310402@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Yamaguchi
Organization Kobe University Hospital
Division name Department of Radiology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-6104
Homepage URL
Email masato03310402@yahoo.co.jp

Sponsor
Institute Department of Radiology, Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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

Management information
Registered date
2018 Year 01 Month 30 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035441

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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