UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014537 |
|---|---|
| Receipt number | R000016906 |
| Scientific Title | A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2017/01/16 18:18:02 |
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Basic information
Public title
A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
Acronym
A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
Scientific Title
A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
Scientific Title:Acronym
A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
Region
| Japan |
Condition
Condition
Large or giant wide neck aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of SJN1301 for large or giant wide neck aneurysm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as < 50% stenosis) of the parent artery of the 12 month follow up angiogram and without any subsequent treatment at the target aneurysm at the 12 month follow up visit.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Placement of SJN1301
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age 20 to 80 years
2.Subject is willing and able to give informed concent
3.Subject has a single targeted intracranial aneurysm that:
-Is located in the internal carotid artery (ICA) distribution up to the terminus
-Is able to be crossed with a standard 0.014" guide wire
-Has a neck >4 mm or no discernible neck and an aneurysm size >10 mm (including saccular, fusiform and dissecting configuration)
-Has a vessel diameter between 2.5 mm and 5.3 mm at both the proximal and distal segments where the implant will be placed
4.Subject is willing to comply to all scheduled 12M-follow up visits and test.
Key exclusion criteria
1.Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
2.Known history of life threatening allergy to contrast dye
3.Known allergy to nickel, chromium cobalt, tungsten or platinum.
4.Subject has documented resistance to clopidogrel/Plavix.
5.Major surgery within previous 30 days or planned in the study follow up
6.Previous intracranial implant within the past 12 weeks prior to treatment date
7.Contraindication to CT scan or MRI
8.Severe neurological deficit that renders the subject incapable of living independently
9.Unstable neurological deficit (i.e worsening of clinical condition in the last 30 days)
10.Evidence of active infection at the time of treatment
11.Dementia or psychiatric problem that prevents the subject from completing required follow up
12.Limit survival to less than 24 months
13.Serum creatinine >=2.5 mg/dL
14.Female subjects who are pregnant or planning to become pregnant within the study period and who are unwilling to take adequate method of contraception for at least until the study follow up
15.Subject with an intracranial mass (tumor, except meningioma, abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
16.Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
17.Subject has a non-treated arterio-venous malformation (AVM) in the territory of the target aneurysm
18.Enrollment in another trial involving an investigational product
19.Subject has a need for long-term use of anticoagulants
20.The patient who are inappropriate for participating in the study in the judgment of the principal investigator or sub-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneyoshi Okawa |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo 112-0004 Japan
TEL
03-6894-8231
muneyoshi.okawa@stryker.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Motohashi |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1, Koraku, Bunkyo-ku, Tokyo 112-0004 Japan
TEL
03-6894-8219
Homepage URL
satoru.motohashi@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
大阪大学医学部附属病院(大阪府), Osaka University Hospital
京都大学医学部附属病院(京都府), Kyoto University Hospital
広南病院(宮城県), Kohnan Hospital
神戸市立医療センター中央病院(兵庫県), Kobe City Medical Center General Hospital
順天堂大学医学部附属順天堂医院(東京都), Juntendo University Hospital
福岡大学病院(福岡県), Fukuoka Univeristy Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 20 | 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
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 20 | 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
| 2014 | Year | 07 | Month | 11 | Day |
Last modified on
| 2017 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016906
