UMIN-CTR Clinical Trial

Basic information
Public title	Multilayer flow modulator for aortic aneurysm and peripheral aneurysm treatment
Acronym	MFM
Scientific Title	Multilayer flow modulator for aortic aneurysm and peripheral aneurysm treatment
Scientific Title:Acronym	MFM
Region	Japan

Condition
Condition	thoracic aortic aneurysm thoracoabdominal aortic aneurysm peripheral aneurysm
Classification by specialty	Vascular surgery Radiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the surgical and mid-term outcome of the multilayer flow modulator for thoracic aortic aneurysm and peripheral aneurysm
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgical and mid-term outcome of MFM(safety and efficacy)
Key secondary outcomes

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	MFM treatment to aortic aneurysm and peripheral aneurysm
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with thoracic aortic aneurysm and thoracoabdominal aortic aneurysm and peripheral aneurysm
Key exclusion criteria	Aortic dissection, dissecting aneurysm shaggy aorta Aortitis syndrome Infective aneurysm ruptured aneurysm contrast media allergy hemorrhagic diathesis,coagulopathy
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshikatsu Saiki
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Surgery
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Email	kkumagai@med.tohoku.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kiichio Kumagai
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Surgery
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-7222
Homepage URL
Email	kkumagai@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 05 Month 01 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	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 16 Day
Date of IRB	2018 Year 03 Month 12 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2021 Year 01 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	2015 Year 05 Month 01 Day
Last modified on	2019 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020142