UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051531 |
|---|---|
| Receipt number | R000058790 |
| Scientific Title | Extra-anatomical left common carotid and subclavian artery bypass followed by aortic arch replacement with frozen elephant trunk |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/05 17:47:19 |
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Basic information
Public title
Extra-anatomical left common carotid and subclavian artery bypass followed by aortic arch replacement with frozen elephant trunk
Acronym
De-branching first technique followed by TARFET
Scientific Title
Extra-anatomical left common carotid and subclavian artery bypass followed by aortic arch replacement with frozen elephant trunk
Scientific Title:Acronym
De-branching first technique followed by TARFET
Region
| Japan |
Condition
Condition
good
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of debranching-first technique followed by total arch replacement using a frozen elephant trunk as a two-stage operation for extensive thoracic aortic aneurysm among high-risk patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated 5-year overall survival rate
Key secondary outcomes
Estimated 5-year aortic event-free survival, aortic reintervention rates
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with diffuse degenerative aneurysms from the aortic arch to the descending aorta or chronic aortic dissection from 2016-2021 in our institution.
Key exclusion criteria
Acute aortic dissection requiring emergency surgery.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Suzuki |
Organization
Shinmatsudo Central General Hospital
Division name
Cardiovascular Surgery
Zip code
270-0034
Address
1-380 Shinmatsudo, Matsudo, Chiba, Japan
TEL
047-345-1111
ryosuzuki0722@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Sekishinnkai Hospital
Division name
Cardiovascular Surgery
Zip code
350-1305
Address
Sayamashi Irumagawa 2-37-20
TEL
+8142963-6611
Homepage URL
ryosuzuki0722@yahoo.co.jp
Sponsor or person
Institute
Shinmatsudo Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Shinmatsudo Central General Hospital
Address
1-380 Shinmatsudo, Matsudo, Chiba, Japan
Tel
047-345-1111
ryosuzuki0722@yahoo.co.jp
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
| 2023 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
50
Results
The assessed technique enables a less technically demanding surgery with reasonable outcomes. The estimated 5-year aortic event-free survival and reintervention rates were acceptable, suggesting that multiple stages of alternative open and endovascular interventions, such as this technique, may reduce the morbidity and mortality rates of high-risk patients with diffuse thoracic aortic aneurysm.
Results date posted
| 2023 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients in this study were predominantly male (81.6%) aged 73.5 years, with various comorbidities, including diabetes mellitus (28.6%) and hyperlipidaemia (53%), and with a history of cerebrovascular events (22.4%) and haemodialysis (8.2%).
Participant flow
Forty-nine consecutive patients with diffuse degenerative aneurysms from the aortic arch to the descending aorta or chronic aortic dissection receiving left common carotid to subclavian artery bypass followed by total arch replacement using a frozen elephant trunk and possible subsequent thoracic endovascular aortic repair between 2016 and 2021.
Adverse events
10% of stroke event. No paraplegia event.
Outcome measures
The operative mortality rate was 4.1%, with no paraplegia events. The estimated five-year overall survival, cumulative aortic related mortality was 76.8%, 2%, respectively. The estimated five-year overall cumulative aortic reintervention rates including intended intervention were 31.3%. The estimated 5-year cumulative rate of non-intended reintervention was 4.5%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessed technique was proven to be effective in mortality and aortic free event.
Management information
Registered date
| 2023 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058790
