UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022147
Receipt number R000019869
Scientific Title Prevention of Type II Endoleak With Embolization of IMA Before Endovascular Aneurysm Repair
Date of disclosure of the study information 2016/04/30
Last modified on 2022/05/09 13:58:17

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Basic information

Public title

Prevention of Type II Endoleak With Embolization of IMA Before Endovascular Aneurysm Repair

Acronym

Prevention of Type II Endoleak

Scientific Title

Prevention of Type II Endoleak With Embolization of IMA Before Endovascular Aneurysm Repair

Scientific Title:Acronym

Prevention of Type II Endoleak

Region

Japan


Condition

Condition

abdominal aortic aneurysm

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prevention of Type II Endoleak

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

occurrence of type2 endoleak

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

embolization of IMA

Interventions/Control_2

no treatment

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

Patient more than 3 mm of diameter IMA.
Patient more than 2 mm of diameter lumbar artery and patient IMA.
Patient of aortoiliac type aneurysm.

Key exclusion criteria

Patient detemined as a unsuitable
Emergency operation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kimikazu
Middle name
Last name Hamano

Organization

Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine

Division name

Division of first surgery

Zip code

755-8505

Address

Ube, 755-8505, Japan

TEL

0836-22-2261

Email

osamu.y@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Samura

Organization

Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine

Division name

Division of first surgery

Zip code

755-8505

Address

Ube, 755-8505, Japan

TEL

0836-22-2261

Homepage URL


Email

m.samura@yamaguchi-u.ac.jp


Sponsor or person

Institute

Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery and Clinical Science, Yamaguchi 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

Center For Clinical Research, Yamaguchi University Hospital

Address

Ube, 755-8505, Japan

Tel

0836-22-2428

Email

me223@yamaguchi-u.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

2016 Year 04 Month 30 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

106

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

Completed

Date of protocol fixation

2014 Year 04 Month 14 Day

Date of IRB

2014 Year 04 Month 14 Day

Anticipated trial start date

2014 Year 04 Month 14 Day

Last follow-up date

2022 Year 03 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

2016 Year 04 Month 30 Day

Last modified on

2022 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019869


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name