UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000144
Receipt number R000000207
Scientific Title Japanese Extracranial-Intracranial Arterial Bypass Trial
Date of disclosure of the study information 2005/09/08
Last modified on 2005/09/08 17:29:11

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Basic information

Public title

Japanese Extracranial-Intracranial Arterial Bypass Trial

Acronym

JET Study

Scientific Title

Japanese Extracranial-Intracranial Arterial Bypass Trial

Scientific Title:Acronym

JET Study

Region

Japan


Condition

Condition

Symptomatic internal carotid artery or middle cerebral artery occlusion or stenosis

Classification by specialty

Medicine in general Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this prospective multicenter trial was to determine whether bypass surgery can prevent stroke recurrence in patients with major cerebral artery occlusive diseases and hemodynamic cerebral ischemia determined by quantitative measurement of cerebral blood flow, and whether improvement in hemodynamic cerebral ischemia by bypass surgery can prevent the progression of neuropsychological disorders or improve neuropsychological function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

1) Completed stroke (Rankin disability scale 3, 4 or 5). 2) Major cardiovascular morbidity and death. 3) Other cause of death and severe disability. 4) Patients who are necessary to undergo additional procedures or a second EC/IC bypass on the same side.

Key secondary outcomes

Completed stroke (Rankin disability scale 3, 4 or 5) due to the occlusive artery enrolled into the study.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Medically-treated group (antiplatelet drug: ticlopidine and/or aspirin)

Interventions/Control_2

Surgically-treated group (arterial bypass surgery with medication of antiplatelet drug)

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

20 years-old <=

Age-upper limit

73 years-old >=

Gender

Male and Female

Key inclusion criteria

1) History: TIA(s) or minor completed stroke(s) in the carotid distribution, within 3 months prior entry. 2) Clinical findings: patients with useful residual function (Rankin disability scale 1 or 2). 3) CT or MRI: normal or border zone infarction. 4) Angiography: uni- or bilateral, ICA or MCA, occlusion or severe stenosis due to arteriosclerosis. 5) Baseline CBF less than 80% of normal control and CVRC less than 10%.

Key exclusion criteria

1) Rankin disability scale 3,4,5. 2) non-atherosclerotic lesion. 3) patients with malignant neoplasm, renal failure, cardiac failure, hepatic failure or lung failure. 4) myocardial infarction within six months. 5) diabetus mallitus with FBS more than 300 mg/dl or during treatment using insulin. 6) diastolic arterial pressure more than 110 mmHg.7) artery to artery embolism, 8) cardioembolism

Target sample size

280


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Ogawa

Organization

Iwate Medical University

Division name

Department of Neurosurgery

Zip code


Address

19-1 Uchimaru, Morioka, Japan

TEL

019-651-5111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kuniaki Ogasawara

Organization

Iwate Medical University

Division name

Department of Neurosurgery

Zip code


Address

19-1 Uchimaru, Morioka, Japan

TEL

019-651-5111

Homepage URL


Email

kuogasa@iwate-med.ac.jp


Sponsor or person

Institute

JET Study Group

Institute

Department

Personal name



Funding Source

Organization

National Cardiovascular Center

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2005 Year 09 Month 08 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

Completed

Date of protocol fixation

1998 Year 08 Month 26 Day

Date of IRB


Anticipated trial start date

1998 Year 11 Month 01 Day

Last follow-up date

2004 Year 04 Month 01 Day

Date of closure to data entry

2004 Year 04 Month 01 Day

Date trial data considered complete

2005 Year 08 Month 01 Day

Date analysis concluded

2005 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 08 Day

Last modified on

2005 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000207


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name