Large or giant wide neck aneurysm
Conditions
Interventions
Placement of SJN1301
Sponsors
Stryker Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactSatoru Motohashi
Stryker Japan K.K. Clinical Affairs
Outcome results
None listed