UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032602
Receipt number R000037169
Scientific Title Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.
Date of disclosure of the study information 2018/05/15
Last modified on 2018/06/30 13:08:14

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Basic information

Public title

Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.

Acronym

Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.

Scientific Title

Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.

Scientific Title:Acronym

Multicenter Retrospective study of Interventional Radiology for Type2 endoleak following EVAR.

Region

Japan


Condition

Condition

Abdominal aortic aneurysm

Classification by specialty

Vascular surgery Radiology Cardiovascular surgery
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the success rate of TAE for T2EL following EVAR and association between technical aspects and aneurysm diameter change.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Aneurysm diameter change following TAE

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The cases treated by EVAR using commercially available device and underwent aneurysm enlargement due to T2EL

The cases who underwent TAE for T2EL from January 2007 to December 2017.

Key exclusion criteria

The cases who underwent surgical treatment for sac enlargement without TAE.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Iwakoshi

Organization

Nara Medical University

Division name

Radiology

Zip code


Address

840 Shijo-cho, Kashihara, Nara 634-8521, Japan

TEL

0744-29-8900

Email

shinichi18548342@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Iwakoshi

Organization

Nara Medical University

Division name

Radiology

Zip code


Address

840 Shijo-cho, Kashihara, Nara 634-8521, Japan

TEL

0744-29-8900

Homepage URL


Email

shinichi18548342@gmail.com


Sponsor or person

Institute

Department of Radiology, Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Self Funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

St. Marianna University Hospital
Nagoya City University Hospital
Kanazawa University Hospital
Gifu University Hospital
Kitazato University Hospital
Tsukuba University Hospital
Iwate Medical University Hospital
Tokai University Hospital
Okinawa Chubu Hospital
Tenri Hospital
Tottori University Hospital
Yamanasi University Hospital
Aichi Medical University Hospital
Kumamoto University Hospital
Osaka University Hospital

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 05 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

Enrolling by invitation

Date of protocol fixation

2018 Year 04 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 07 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

age, sex, aneurysm diameter, device used for EVAR, emboloic material for TAE,


Management information

Registered date

2018 Year 05 Month 15 Day

Last modified on

2018 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name