UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047713
Receipt number R000054382
Scientific Title The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/11 08:42:31

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Basic information

Public title

The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"

Acronym

The Long-term Follow-up for Preventing Type II Endoleak with Embolization of IMA

Scientific Title

The observational study for the long-term follow-up of the participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"

Scientific Title:Acronym

The Long-term Follow-up for Preventing Type II Endoleak with Embolization of IMA

Region

Japan


Condition

Condition

Abdominal aortic aneurysm

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the long-term outcomes of endovascular aortic repair with IMA embolization for the prevention of Type II endoleak.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occurrence of Type II endoleak

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The alive participants of the preceding study "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair"

Key exclusion criteria

Not applicable

Target sample size

86


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

Surgery I

Zip code

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2261

Email

surg-1@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Yuriko
Middle name
Last name Takeuchi

Organization

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

Division name

Surgery I

Zip code

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi, Japan

TEL

0836-22-2261

Homepage URL


Email

takey@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

Minami-kogushi 1-1-1, Ube, Yamaguchi, 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

2022 Year 05 Month 16 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

2022 Year 02 Month 15 Day

Date of IRB

2022 Year 02 Month 15 Day

Anticipated trial start date

2022 Year 02 Month 15 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is an observational study. Participants of the prospective randomized controlled trial "Prevention of Type II Endoleak with Embolization of IMA Before Endovascular Aneurysm Repair" performed (UMIN ID: UMIN000022147) are eligible. The endpoints of this study are following, occurrence of Type II endoleak, changes in aneurysmal diameter, and overall survival.


Management information

Registered date

2022 Year 05 Month 11 Day

Last modified on

2022 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name