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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023872
Receipt No. R000027497
Scientific Title Fenestrated and branched stentgrafting based on customized Zenith and i-Cast for abdominal aortic aneurysms with concomitant iliac aneurysms, pararenal aortic aneurysms, and thoracoabdominal aortic aneurysms
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/31

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Basic information
Public title Fenestrated and branched stentgrafting based on customized Zenith and i-Cast for abdominal aortic aneurysms with concomitant iliac aneurysms, pararenal aortic aneurysms, and thoracoabdominal aortic aneurysms
Acronym Fenestrated and branched stentgrafting for abdominal aortic aneurysms with concomitant iliac aneurysms, pararenal aortic aneurysms, and thoracoabdominal aortic aneurysms.
Scientific Title Fenestrated and branched stentgrafting based on customized Zenith and i-Cast for abdominal aortic aneurysms with concomitant iliac aneurysms, pararenal aortic aneurysms, and thoracoabdominal aortic aneurysms
Scientific Title:Acronym Fenestrated and branched stentgrafting for abdominal aortic aneurysms with concomitant iliac aneurysms, pararenal aortic aneurysms, and thoracoabdominal aortic aneurysms.
Region
Japan

Condition
Condition abdominal aortic aneurysms with concomitant iliac aneurysms
pararenal aortic aneurysms
thoracoabdominal aortic aneurysms
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of safety and efficacy with fenestrated or branched stentgraft for AAA with IAA, PAA, and TAAA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 30-day mortality
Major adverse events
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endovascular surgery
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1.In need of treatment
2.anatomically possible of stentgraft insertion

3.patients with follow-up of compliance can be kept
4.Informed consent was obtained
Key exclusion criteria 1.Angiography or anticoagulant therapy is contraindicated
2.concerned metal allergy
3.systemic infection, involving the risk of stent infection increases
4.Uncontrollable blood clotting disorder
5.Patient in need of systemic immunosuppressive therapy
6.Pregnant women
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takao Ohki
Organization Jikei university school of medicine
Division name Department of surgery, division of vascular surgery
Zip code
Address 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email takohki@msn.com

Public contact
1st name of contact person
1st name
Middle name
Last name Reo Takizawa
Organization Jikei university school of medicine
Division name Department of surgery, division of vascular surgery
Zip code
Address 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email reo.takizawa@gmail.com

Sponsor
Institute Jikei university school of medicine
Institute
Department

Funding Source
Organization Self funding
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
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
2016 Year 09 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 Enrolling by invitation
Date of protocol fixation
2007 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2016 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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