Patients with unruptured wide-neck intracranial aneurysms
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Stent system(BS054)
Dose form / Japanese Medical Device Nomenclature:OTHER
Occlusion Coil/ Artificial Embolization Device for Main Circulatory System
Rout
Sponsors
Boston Scientific Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Unruptured wide neck intracranial aneurysm 2)The parent artery diameter within the range of 2.0 to 4.5 mm. 3)The target intracranial aneurysm is difficult to be treated by surgery and coil embolization with the use of embolization coils alone. etc.
Exclusion criteria
Exclusion criteria: 1)The target intracranial aneurysm has a history of rupture. 2)Stent implantation in the neck or cranium within 4 weeks before the study procedure. 3)Two or more untreated intracranial aneurysms with the maximum diameters of >= 10 mm. 4)The access of the Stent to the target intracranial aneurysm is considered impossible anatomically or procedurally by angiography, or the access to the intracranial aneurysm is impossible because of severe vasospasm refractory to medications. 5)The patient has hemorrhagic diathesis. 6)Antiplatelet/anticoagulation therapy is contraindicated. 7)The patient has a complication of a disease condition causing cardiogenic cerebral infarction. 8)Renal failure (serum creatinine >= 2.0 mg/dL). etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural Success | — |
Countries
Japan
Contacts
Public ContactYasuyuki Inatsugu
Stryker Japan K.K.
Outcome results
None listed