UMIN-CTR Clinical Trial

Public title

Early and mid-term outcomes of endovascular treatment for chronic aneurysmal aortic dissection

Acronym

EVT for CAAD

Scientific Title

Early and mid-term outcomes of endovascular treatment for chronic aneurysmal aortic dissection

Scientific Title:Acronym

EVT for CAAD

Region

Japan

Condition

CAAD

Classification by specialty

Vascular surgery

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate endovascular treatment for enlarged chronic aneurysmal aortic dissection

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

death
paraplegia
complete thrombosis of false lumen

Key secondary outcomes

freedom from re-entry closure
freedom from secondary intervention
remodeling of aorta

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endovascular treatment for CAAD
1-10years

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 clinical course that had elapsed at least one year after the onset of dissection

Key exclusion criteria

acute dissection

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Kanaoka

Organization

Jikei University School of Medicine

Division name

Division of Vascular Surgery, Department of Surgery

Zip code

Address

NishiShinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

yujikana@msn.com

Name of contact person

1st name
Middle name
Last name	Yuji Kanaoka

Organization

Jikei University School of Medicine

Division name

Division of Vascular Surgery, Department of Surgery

Zip code

Address

NishiShinbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL

Email

yujikana@msn.com

Institute

Division of Vascular Surgery, Department of Surgery Jikei University School of Medicine

Institute

Department

Personal name

Organization

Division of Vascular Surgery, Department of Surgery Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Other

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

東京慈恵会医科大学

Date of disclosure of the study information

2016

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Early outcomes
No significant differences were observed between the two groups in terms of age, sex, duration from dissection onset to treatment, maximum short axis diameter of the CAAD, preoperative condition, and follow-up observation period, although the duration from dissection onset to treatment tended to be longer in the CE group than in the PE group. Operative death occurred in 1 out of 74 patients (1.4%); 2.3% in the PE group and 0% in CE group. Technical success in the PE and CE groups were 97.6% and 96.8%, respectively. The device most commonly used to perform entry closure was the TAG (W. L. Gore & Associates, Inc., Flagstaff AZ, USA), and no significant difference in the frequency of use was observed between the two groups.

In the patient that died in the PE group, the tear in the arch could not be closed; therefore, the carotid artery was concomitantly reconstructed using the Chimney method. Furthermore, due to the fact that this patient previously underwent coronary artery bypass grafting using the left internal thoracic artery, the SG was extended proximally after creating a bypass from the left common carotid artery to the left subclavian artery. However, the entry site could not be completely closed and blood pressure decreased during surgery. Unfortunately, the patient died from cardiac failure on the same day due to prolonged hypotension. In one patient in the CE group, we attempted to close a renal artery tear, but a new intimal tear formed. In this case, conversion to open surgical repair was performed the next day and the patient was eventually discharged from the hospital without any major complications. In another patient in the CE group, no central nervous or spinal cord complications were observed, except for delayed paraplegia on postoperative day (POD) 2.

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

No longer recruiting

Date of protocol fixation

2016

Year

10

Month

20

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

20

Day

Last follow-up date

Date of closure to data entry

2017

Year

05

Month

02

Day

Date trial data considered complete

2017

Year

05

Month

02

Day

Date analysis concluded

2017

Year

05

Month

02

Day

Other related information

Aortic remodeling
Review of aortic remodeling in the PE group revealed that closure of entry sites that were mainly located on the aortic arch caused rapid expansion of the true lumen of the aortic arch and the descending thoracic aorta. We also observed gradual shrinkage of the diameter of the entire aorta. However, although we observed an expansion of the true lumen of the abdominal aorta, no changes in the aortic diameter were observed. In addition, we discovered that the expansion of the true lumen was approximately 1.8-fold in the thoracic aorta versus 1.3-fold in the abdominal aorta (Table 4). These results indicated that the degree of expansion was also limited.

Registered date

2016

Year

10

Month

21

Day

Last modified on

2017

Year

05

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028207