UMIN-CTR Clinical Trial

Basic information
Public title	Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Acronym	Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Scientific Title	Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Scientific Title:Acronym	Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Region	Japan

Condition
Condition	abdominal and iliac aneurysm
Classification by specialty	Vascular surgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to analyze if a vascular functional test predicts buttock pain after interventional hypogastric artery occlusion in patients with endovascular aneurysm repair
Basic objectives2	Others
Basic objectives -Others	vascular functional test (Flow-mediated vasodilation / nitroglycerin-mediated vasodilation), treadmill exercise test
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occurrences rate of buttock pain
Key secondary outcomes	course of walking ability

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	vascular functional test(preoperative)/ treadmill exercise test (preoperative, postoperative after 1.2.3.4.5.6 months)
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	patients scheduled to be performed endovascular aneurysm repair with interventional hypogastric occlusion
Key exclusion criteria	1) buttock pain with neurogenic disorder 2) active inflammatory disease 3) contraindication for vascular functional test, treadmill exercise test 4) mental disorder
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Daijirou Middle name Last name Akamatsu
Organization	Tohoku University Hospital
Division name	devision of vascular surgery
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL	022-717-7214
Email	daijirou@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Daijirou Middle name Last name Akamatsu
Organization	Tohoku University Hospital
Division name	devision of vascular surgery
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL	022-717-7214
Homepage URL
Email	daijirou@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital devision of vascular surgery
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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 Tohoku University Hospital
Address	1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.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 21 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	Bilateral hypogastric artery embolization has more adverse effect on the hemodynamics of the gluteal circulation and subjective symptoms than unilateral embolization. These findings may help to consider strategy of hypogastric artery reconstruction.
Results date posted	2020 Year 06 Month 20 Day
Results Delayed	Delay expected
Results Delay Reason	We have written the manuscript and applied to journal.
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	2017 Year 01 Month 01 Day
Date of IRB	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2021 Year 11 Month 30 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 12 Month 17 Day
Last modified on	2022 Year 06 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029113