UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010373
Receipt number R000012138
Scientific Title Direct endvascular thrombectomy for acute internal carotid artery occlusion
Date of disclosure of the study information 2013/03/31
Last modified on 2014/09/30 09:40:42

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Basic information

Public title

Direct endvascular thrombectomy for acute internal carotid artery occlusion

Acronym

Direct thrombectomy of acute ICA occlusion

Scientific Title

Direct endvascular thrombectomy for acute internal carotid artery occlusion

Scientific Title:Acronym

Direct thrombectomy of acute ICA occlusion

Region

Japan


Condition

Condition

acute ICA occlusive ischemic stroke within 3.5 hours from oncet

Classification by specialty

Neurology Vascular surgery Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We clarify whether direct endvascular thrombectomy is more effective than combination therapy of intravenous t-PA and endvascular thrombectomy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the modified Rankin Scale at three-months and categorized as favourable (modified Rankin Scale 0-2)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

To recanalize for acue ICA occlusion,
direct endovascular thrombectomy is performed.

Interventions/Control_2

First intravenous t-PA therapy is performed, and if neurological sign is not improved after 30 minutes, endvascular thrombectomy is performed.

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.Ischemic stroke within 3.5 hours from symptoms onset
2.Acute ICA occlusion on MRI
3.Patients are defined as eligible to receive intravenous t-PA therapy.

Key exclusion criteria

1.The agreement of a patient or the family is not provided.
2.MRI is impossible.
3.Endovascular therapy is impossible.
4.Intravenous t-PA therapy is contraindicated.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Inoue

Organization

Kawasaki Medical School

Division name

Stroke Medicine

Zip code


Address

577, Matsushima, Kurashiki-city Okayama

TEL

086-462-1111

Email

inouet@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Inoue

Organization

Kawasaki Medical School

Division name

Stroke Medicine

Zip code


Address

577, Matsushima, Kurashiki-city Okayama

TEL

086-462-1111

Homepage URL


Email

inouet@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2013 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 03 Month 31 Day

Last modified on

2014 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012138


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name