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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005430
Receipt No. R000006443
Scientific Title Inoue Stentraft Implantation for Aortic Aneurysm and Dissectioin
Date of disclosure of the study information 2011/04/13
Last modified on 2017/07/07

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Basic information
Public title Inoue Stentraft Implantation for Aortic Aneurysm and Dissectioin
Acronym Inoue Stentraft Implantation
Scientific Title Inoue Stentraft Implantation for Aortic Aneurysm and Dissectioin
Scientific Title:Acronym Inoue Stentraft Implantation
Region
Japan

Condition
Condition Aortic Aneurysm and Aortic Dissection
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the long term clinical outcome of Inoue stentgraft for aortic aneurysm and dissection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes technical success, perioperative mortality, incidence of complication
Key secondary outcomes Event free survival of total death, aneurysm related death,second intervention and surgical conversion.

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 perform stentgraft implantation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient of aortic aneurysm and dissection. Surgical treatment is high risk because of complicating disorder. The morphology of aneurysm and dissection is appropriate for stentgraft implantation.
Key exclusion criteria The morphology of aneurysm and dissection is not appropriate for stentgraft implantation because of the occlusion, calcification and meandering of artery.

The massive atheroma or thrombi at the landing zone of stentgraft.

Pregnant or breast feeding female

Uncontrollable blood-clotting disorder

Systemic infection
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4255
Email taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Tazaki
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 075-751-4255
Homepage URL
Email jun1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization PTMC institute
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor PTMC institute
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 13 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/28583734
Publication of results Partially published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28583734
Number of participants that the trial has enrolled
Results
All deployments of branched ISGs were successful. The 30-day mortality was 4.5% (single branch, 3.1%; double branch, 0%; triple branch, 29%), and periprocedural stroke was 16% (single branch, 7.8%; double branch, 33%; triple branch, 42%). At 1 and 5 years, freedom from aneurysm-related death was 93% and 93%, respectively, and freedom from all-cause death was 85% and 59%, respectively. Survival free of major adverse events was 76% at 5 years. The cumulative incidence of stroke was 11% at 5 years. Three patients underwent surgical conversion because of persistent type I endoleak. One branch graft occlusion was observed at the left subclavian artery in a patient who received a double-branched graft.
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
2011 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2011 Year 04 Month 13 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006443

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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