UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023872
Receipt number 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 18:09:46

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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

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

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 or person

Institute

Jikei university school of medicine

Institute

Department

Personal name



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

Value
https://center6.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