UMIN-CTR Clinical Trial

Public title

Use of the Zenith; Dissection Endovascular System in the Treatment of Patients
with Acute, Complicated Type B Aortic Dissection

Acronym

Use of the Zenith; Dissection Endovascular System in the Treatment of Patients
with Acute, Complicated Type B Aortic Dissection

Scientific Title

Use of the Zenith; Dissection Endovascular System in the Treatment of Patients
with Acute, Complicated Type B Aortic Dissection

Scientific Title:Acronym

Use of the Zenith; Dissection Endovascular System in the Treatment of Patients
with Acute, Complicated Type B Aortic Dissection

Region

Japan

North America

Condition

Acute, Complicated Type B Aortic Dissection

Classification by specialty

Vascular surgery	Radiology	Cardiovascular surgery
Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To collect safety and effectiveness date from clinical use of the TXD-2

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The primary safety endpoint will be rate of freedom from major adverse events at 30 days. The primary effectiveness endpoint will be the survival rate at 30 days.

Key secondary outcomes

ability to deliver and deploy the device(s), clinical utility measures, major adverse events, retrograde progression of dissection, changes in true and false lumen sizes, presence of and sources for false lumen flow, extent of false lumen thrombosis, reinterventions, and device integrity

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

Stent graft deploy

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

A patient is deemed suitable for inclusion in the study if the patient has an acute, complicated, Type B aortic dissection with at least one of the following characteristics :
1)Aortic rupture; or
2)Branch vessel obstruction/compromise resulting in malperfusion

Key exclusion criteria

General Exclusion Criteria
1)Age < 18 years;
2)Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);
3)Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
4)Unwilling or unable to comply with the follow-up schedule;
5)Inability or refusal to give informed consent; or
6)Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)

*Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.

Target sample size

67

Name of lead principal investigator

1st name
Middle name
Last name	Cook Research Incorporated

Organization

Cook Research Incorporated

Division name

President

Zip code

Address

1 Geddes Way West Lafayette, IN 47906 US

TEL

+1-765-463-7537

Email

Jennifer.Kerr@CookMedical.com

Name of contact person

1st name
Middle name
Last name	Emiko Mori

Organization

Cook Incorporated

Division name

Clinical Affairs

Zip code

Address

Nakano Central Park East, Nakano 4-10-1, Nakano, Tokyo, Japan

TEL

03-6853-9450

Homepage URL

Email

cookjapan-com@umin.net

Institute

Cook Research Incorporated

Institute

Department

Personal name

Organization

Cook Research Incorporated

Organization

Division

Category of Funding Organization

Profit organization

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

大阪大学医学部附属病院、東京慈恵会医科大学附属病院

Date of disclosure of the study information

2012

Year

10

Month

22

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

11

Month

04

Day

Date of IRB

2012

Year

11

Month

20

Day

Anticipated trial start date

2013

Year

02

Month

01

Day

Last follow-up date

2019

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

2020

Year

03

Month

16

Day

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

15

Day

Last modified on

2020

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010688