UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005430 |
|---|---|
| Receipt number | 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 09:22:24 |
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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
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
jun1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006443
