UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026888
Receipt number R000029866
Scientific Title Tama-Registry of Acute endovascular Thrombectomy
Date of disclosure of the study information 2017/04/06
Last modified on 2022/04/05 16:43:43

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Basic information

Public title

Tama-Registry of Acute endovascular Thrombectomy

Acronym

TREAT

Scientific Title

Tama-Registry of Acute endovascular Thrombectomy

Scientific Title:Acronym

TREAT

Region

Japan


Condition

Condition

Acute cerebral major artery occlusion treated with endovascular thrombectomy

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify treatment status and clinical results of acute endovascular thrombectomy for major cerebral artery occlusion in Tama district, Tokyo, and also obtain a basis for comparative studies.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) The number of treated cases of acute endovascular thrombectomy and death within 90 days after the onset
2) modified Rankin Scale at 90 days (+/- 10 days) after onset

Key secondary outcomes



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

1)Patients who underwent acute endovascular thrombectomy
2)Patients who were treated in the hospital of Tama district in Tokyo
3)Patients admitted from Jan 1st 2015 to Dec 31th 2019
4)The patients with large vessel occlusion (ICA, MCA, ACA, VA, BA, PCA)

Key exclusion criteria

Patients who are considered inappropriate to participate in the study are excluded.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Teruyuki
Middle name
Last name Hirano

Organization

Kyorin University Faculty of Medicine

Division name

Department of Stroke and Cerebrovascular Medicine

Zip code

1818611

Address

6-20-2, Sinkawa, Mitaka, Tokyo, Japan 181-8611

TEL

0422-47-5511

Email

terry@ks.kyorin-u.ac.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Ota

Organization

Tokyo Metropolitan Tama Medical Center

Division name

Department of Neurosurgery

Zip code

1838524

Address

2-8-29 Musasi-dai, Fuchu, Tokyo, Japan 183-8524

TEL

042-323-5111

Homepage URL


Email

takahiro_oota@tmhp.jp


Sponsor or person

Institute

Department of Stroke and Cerebrovascular Medicine, Kyorin Univiersity Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

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

Ethical committee, Kyorin University

Address

6-20-2, Sinkawa, Mitaka, Tokyo, Japan 181-8611

Tel

0422-47-5511

Email

irb@ks.kyorin-u.ac.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

北原国際病院,杏林大学, 公立昭和病院, 公立福生病院, 災害医療センター, 佐々総合病院, 多摩総合医療センター, 東京医科大学八王子医療センター, 東海大学医学部附属八王子病院,日本医科大学多摩永山病院, 武蔵野赤十字病院


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 06 Day


Related information

URL releasing protocol

https://tamatreat.jp/

Publication of results

Published


Result

URL related to results and publications

https://www.strokejournal.org/article/S1052-3057(18)30441-5/fulltext

Number of participants that the trial has enrolled

2247

Results

Regionwide Retrospective Survey of Acute Mechanical Thrombectomy in Tama, Suburban Tokyo: A Preliminary Report.
Ota T, Shigeta K, Amano T, Ueda M, Hirano T, Matsumaru Y, Shiokawa Y.
J Stroke Cerebrovasc Dis. 2018 Nov;27(11):3350-3355.

Results date posted

2022 Year 04 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

2247cases

Participant flow

2247 cases registered.

Adverse events

None

Outcome measures

Primaryoutcome:GoodclinicaloutcomewasdefinedasmRS0-2at90days.
Secondaryoutcomes:Relevancebetweenemergencytransportsystemandtherapyduration,locationofpatient'saccommodationandtimeatwhichtherapyensued,andcomparisonsbetweendirecttransportandtransfercasesintermsoftimesrelatedtotherapy,thera-peuticcomplications,andoutcome.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 03 Day

Date of IRB

2017 Year 04 Month 03 Day

Anticipated trial start date

2017 Year 04 Month 06 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Primary endopoint
modified Rankin Scale at 90 days (+/- 10 days) after onset


Management information

Registered date

2017 Year 04 Month 06 Day

Last modified on

2022 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name