This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intervention Description
Kobe City General Hospital
Kobe, Hyōgo, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Kyoto University Hospital
Kyoto, Japan
Safety evaluation: Any stroke or death related to the procedure within 180 days
Time frame: 180 days after the procedure
Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure
Time frame: 180 days after the procedure
Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel)
Time frame: 180 days after the procedure
Any death within 180 days after the procedure
Time frame: 180 days after the procedure
Any death by neurological reason within 180 days after the procedure
Time frame: 180 days after the procedure
Any adverse event or adverse device effect
Time frame: 180 days after the procedure
Neurological assessment (scale ; mRS)
Time frame: 180 days after the procedure
Neurological assessment (scale ; Barthel Index)
Time frame: 180 days after the procedure
Neurological assessment (scale ; NIHSS)
Time frame: 30 days after the procedure
Neurological assessment (scale ; GCS)
Time frame: 30 days after the procedure
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