Safety and efficacy of the stabilizer device
- Conditions
- cerebral aneurysm
- Registration Number
- JPRN-jRCTs052210098
- Lead Sponsor
- sakai nobuyuki
- Brief Summary
Primary endpoint, defined hemorrhagic complication, did not occur because the trial device was stable without unexpected movements. Secondary endpoint for safety, defined 1; ischemic stroke, 2; arterial dissection, 3; vasospasm, did not occur. 4; other adverse event, transient finger fine movement disturbance occurred just after treatment in 1 case, but disappeared spontaneously and no ischemic change on MRI at next day of treatment. This even is not related to device and treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 5
1)Patients who are scheduled to have a flow divertor or coil-assisted stent for cerebral aneurysm
2) Patients who are expected to have difficulty delivering the catheter to the treatment site.
3)Patients aged between 20years and 80years old at the time of concent acquisition
4)Patients who consented to the study in writing
1)A history of hypersensitivity to nickel or titanium
2)A patient who is judged by the principal investigator to be inappropriate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hemorrhagic stroke
- Secondary Outcome Measures
Name Time Method ischemic stroke,success of exchange catheters,arterial dissection,vasospasm,adverse event ,Delivery of catheter to treatment site