UMIN-ICDS Clinical Trial

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

good

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Estimated 5-year overall survival rate

Key secondary outcomes

Estimated 5-year aortic event-free survival, aortic reintervention rates

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ryosuzuki0722@yahoo.co.jp

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

Email

ryosuzuki0722@yahoo.co.jp

Institute

Shinmatsudo Central General Hospital

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shinmatsudo Central General Hospital

Address

1-380 Shinmatsudo, Matsudo, Chiba, Japan

Tel

047-345-1111

Email

ryosuzuki0722@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

06

Day

URL releasing protocol

N/A

Publication of results

Partially published

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

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 related information

Assessed technique was proven to be effective in mortality and aortic free event.

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/icdr_e/ctr_view.cgi?recptno=R000058790