UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025446
Receipt number R000029285
Scientific Title Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair.
Date of disclosure of the study information 2016/12/28
Last modified on 2022/07/19 22:36:44

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Basic information

Public title

Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair.

Acronym

Hemodynamic assessment of endoleak with 4D-flow MRA

Scientific Title

Hemodynamic assessment of endoleak using three-dimensional phase contrast magnetic resonance imaging in patients who underwent endovascular aneurysm repair.

Scientific Title:Acronym

Hemodynamic assessment of endoleak with 4D-flow MRA

Region

Japan


Condition

Condition

Abdominal aortic aneurysm

Classification by specialty

Surgery in general Vascular surgery Radiology
Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Three-dimensional phase contrast MRI(4D-flow) enables the assessment of arterial hemodynamics, flow vector, flow volume. Endoleaks can be associated with postoperative aneurysmal growth. The aim of this study is to demonstrate the utility of the hemodynamic assessment of endoleak with 4D-flow in association with post-EVAR AAA enlargement.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hemodynamic parameters using MRI (flow volume, flow velocity, flow vector).
Endoleak vessel diameter. Identification of persistent endoleak. Prognosis of post-EVAR AAA
The occurrence of clinical events.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent endovascular aneurysm repair.

Key exclusion criteria

1) emergency surgery
2) Patients who underwent EVAR with non-nitinol-stentgraft
3) Inability to obtain informed consent
4) Claustrophobia
5) Contraindication of contrast enhanced MRI
6) Inappropriate patients due to other reasons.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Unno

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code

431-3192

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Email

unno@hama-med.ac.jp


Public contact

Name of contact person

1st name Naoki
Middle name
Last name Unno

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code

431-3192

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Homepage URL


Email

unno@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of education, culture, sports, science, and technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Hamamatsu University School of Medicine

Address

1-20-1, Handayama, Higashi-ku, Hamamatsu, JAPAN

Tel

053-435-2680

Email

rinri@hama-med.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 12 Month 28 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

155

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

No longer recruiting

Date of protocol fixation

2013 Year 01 Month 01 Day

Date of IRB

2014 Year 04 Month 25 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: single-center cohort study
Objective: Patients who underwent endovascular abdominal aortic aneurysm repair between January 1, 2013 and December 31,2015.
Measurements: Hemodynamics of endoleaks, Maximum aneurysmal diameter, Endoleak vessel diameter.


Management information

Registered date

2016 Year 12 Month 27 Day

Last modified on

2022 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name