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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000144
Receipt No. 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

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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
Institute JET Study Group
Institute
Department

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
URL(English) https://upload.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


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