UMIN-CTR Clinical Trial

Public title

Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection

Acronym

Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection

Scientific Title

Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection

Scientific Title:Acronym

Determination of effective remodeling duration after thoracic endovascular repair for type B aortic dissection

Region

Japan

Condition

Stanford type B dissecting aortic aneurysm

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of the entry closure using a stent graft indicated for aortic dissection (CTAG) in patients with Stanford type B dissecting aortic aneurysm and to determine the duration from the onset of aortic dissection that allows effective aortic remodeling to occur (effective remodeling duration or ERD).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy primary endpoint
Aortic remodeling rate at 6 months post-procedure
Safety primary endpoint
Mortality and MAE incidence rate at 30 days post-procedure

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Treat Stanford type-B dissection with stent graft and follow up with patients for 12 months post-operatively.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1The false lumen of aortic dissection meets all of the following conditions.
To reside beyond the origin of the left subclavian artery
Blood flows inside the false lumen (double-barrel type or partial thrombosis).
Existence of the false lumen in size of ≥5 mm in the descending aorta (distal to the site where the endoprosthesis is going to be inserted.)
2.The condition of aortic dissection meets any of the following:
a.Rupture
b.Malperfusion syndrome
c.Maximum diameter of the dissecting aorta not less than 40 mm
d.Rapid dilatation of the dissection lumen (≥5 mm/year)
e.Partial thrombosis
f.Persistent pain
g.Hypertension that is difficult to control
3.The stent-graft implantation site meets all of the following conditions.
a.The most proximal extent of the implantation site is a non-dissected area.
b.Aortic diameter of 16–42 mm, sealing distance from the primary entry tear of ≥20 mm
c.No severe calcification or high volume of mural thrombi.
4.The proximal end of stent graft is distal to the brachiocepharic artery / Zone 1 .
5.After the nature of the study is fully explained, the subject or subject's legally acceptable representative has consented and signed an informed consent form, which had been approved by the Institutional Review Board of each study center.
6.The subject and treating surgeon have agreed that the subject is to return to the hospital on all necessary follow-up visits after implantation.

Key exclusion criteria

1.Less than 20 years of age
2.Patients with unknown date of onset of dissection
3.Absence of false lumen 5mm or greater in the descending aorta(distal to potential implantation site)
4.A lesion of the basilar aorta, ascending aorta, aortic arch, or abdominal aorta, which requires treatment
5.Treatment history of aneurysms of the aortic arch, descending aorta, or abdominal aorta
6.Patients with infective aortitis or systemic infection for whom endoprosthesis infection is suspected.
7.Continuously in shock state
8.Complication of severe organ disorder
a.Low cardiac function
b.Advanced Mitral/Aortic regurgitation
c.Low respiratory function
d.Hepatic cirrhosis
e.Irreversible renal failure
9.Patients who have undergone coronary angioplasty within 2 weeks of the procedure
10.Patients with untreated and clinically significant coronary artery disease which requires revascularization
11.Patients with active peptic ulcer
12.Patients who have had cerebral infarction within 4 weeks after the procedure
13.Patients with a life expectancy of less than 12 months due to a non-aortic-related pre-operative complication
14.Pregnant women
15.Major surgery within 30 days of the procedure
16Connective tissue disorder
17.Participation in another clinical study in the past year
18.History of drug abuse, such as narcotics
19.Tortuous aorta or iliac artery for which the endoprosthesis access is considered impossible
20.A case that requires celiac artery closure as a part of treatment
21.Patients to be treated with devices other than CTAG
22.With history of allergy to endoprosthesis materials or contrast agent
23.Other patients for which treatment with endoprosthesis intervention under general anesthesia is considered inappropriate

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Sawa

Organization

Osaka University Hospital

Division name

Department of Cardiovascular Surgery

Zip code

Address

2-15 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3154

Email

tsakamoto8112@gmail.com

Name of contact person

1st name
Middle name
Last name	Tomohiko Sakamoto

Organization

Osaka University Hospital

Division name

Department of Cardiovascular Surgery

Zip code

Address

2-15 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3154

Homepage URL

Email

tsakamoto8112@gmail.com

Institute

Osaka University Graduate school of medicine

Institute

Department

Personal name

Organization

Osaka University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2013

Year

09

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

02

Month

13

Day

Date of IRB

2012

Year

11

Month

06

Day

Anticipated trial start date

2012

Year

11

Month

18

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

11

Day

Last modified on

2020

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013697