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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name