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
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
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
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
