UMIN-CTR Clinical Trial

Public title

Japanese Extracranial-Intracranial Arterial Bypass Trial-2 Study

Acronym

JET-2 Study

Scientific Title

Japanese Extracranial-Intracranial Arterial Bypass Trial-2 Study

Scientific Title:Acronym

JET-2 Study

Region

Japan

Condition

Symptomatic occlusion or stenosis of internal carotid artery or middle cerebral artery

Classification by specialty

Medicine in general	Neurology	Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This prospective study is designed to answer a question if there are potential candidates for extracranial-intracranial bypass surgery in patients with mild cerebral ischemia due to recently symptomatic occlusive lesions in the carotid artery territory.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1.Completed stroke (Rankin disability scale3,4,5) 2.Vascular death 3.Death and severe disability of other causes 4.Bypass surgery requested by neurologists due to impending stroke on the ipsilateral side

Key secondary outcomes

1.Ipsilateral stroke (Rankin disability scale3,4,5) 2.Death due to ipsilateral stroke

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

73

years-old

>=

Gender

Male and Female

Key inclusion criteria

Recently symptomatic cerebral ischemic attacks due to occlusive lesions in the carotid territory demonstrated by cerebral angiography or magnetic resonance angiography. Transient ischemic attack (TIA) or ischemic minor stroke in the hemispheric carotid territory on the side of the occlusive lesions. Most recent qualifying TIA or stroke occurring within 6 months prior to enrollment. Age less than or equal to 73 years old. Modified Rankin Scale: 0-2. Competent to give informed consent Computed tomography (CT) or MRI demonstrating no diffuse cerebral infarction or no enhancement after infusion of contrast agent. Angiography showing occlusion or severe stenosis of internal carotid artery or middle cerebral artery trunk (M1). Quantitative measurement of cerebral blood flow (CBF) by positron emission tomography (PET), single photon emission computed tomography (SPECT), xenon-CT performed at least 3 weeks after the most recent attack. Cerebrovascular reserve capacity (CVR) is defined as [(CBF after infusion of acetazolamide-rest CBF)/ rest CBF] X 100% Definition of Groups Mild cerebral ischemia is classified into 4 groups based on the rest CBF and CVR. A: 80%

Key exclusion criteria

1. Severe neurological conditions (Rankin disability scale 3,4,5) 2. Non-atherosclerotic vascular disease of caotid artery territory 3. Malignancy, renal insufficiency, heart failure, hepatic failure, renal failure 4. Acute myocardial infarction within previous 6months 5. Fasting glucose level > 300mg/dl, 6. Diastolic blood pressure >110mmHg 7. Artery to artery embolism 8. Cardioembolism 9. Acute, progressing or unstable neurological deficit

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Susumu Miyamoto

Organization

National Cardiovascular Center

Division name

Neurosurgery

Zip code

Address

5-7-1, Fujishiro-dai, Suita, Osaka, Japan

TEL

06-6833-5012

Email

Name of contact person

1st name
Middle name
Last name	Koji Iihara

Organization

National Cardiovascular Center

Division name

Neurosurgery

Zip code

Address

5-7-1, Fujishiro-dai, Suita, Osaka, Japan

TEL

06-6833-5012

Homepage URL

Email

kiihara@hsp.ncvc.go.jp

Institute

JET-2 Study Group

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2005

Year

09

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2004

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2004

Year

04

Month

01

Day

Last follow-up date

2009

Year

03

Month

01

Day

Date of closure to data entry

2009

Year

03

Month

01

Day

Date trial data considered complete

2009

Year

03

Month

01

Day

Date analysis concluded

Other related information

Enrolled patients receive antiplatelet agents for the following 2 years. The incidence of the endpoints are to be compared between subgroups. Neurocognitive function and CBF are estimated at regular intervals during 2 years after enrollment and these changes are compared between subgroups.Enrolled patients receive antiplatelet agents for following 2 years.

Registered date

2005

Year

09

Month

12

Day

Last modified on

2007

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000240