UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective, multi-center, single-arm study of SJN1301 to treat large or giant wide neck aneurysm
Title of the study (Brief title)	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	Muneyoshi Okawa
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
Address	2-6-1, Koraku, Bunkyo-ku, Tokyo 112-0004 Japan
TEL	03-6894-8231
Email	muneyoshi.okawa@stryker.com

Public contact
Name of contact person	Satoru Motohashi
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
Address	2-6-1, Koraku, Bunkyo-ku, Tokyo 112-0004 Japan
TEL	03-6894-8219
Homepage URL
Email	satoru.motohashi@stryker.com

Sponsor
Institute	Stryker Japan K.K.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016906