Safety and efficacy of the stabilizer device

JRCT ID: jRCTs052210098

Registered date:04/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cerebral aneurysm
• Date of first enrollment: 25/10/2021
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Assisting delivery with stabilizer devices for patients who have difficulty delivering catheters to the treatment site during endovascular treatment,

Outcome(s)

• Primary Outcome: hemorrhagic stroke
• Secondary Outcome: ischemic stroke,success of exchange catheters,arterial dissection,vasospasm,adverse event ,Delivery of catheter to treatment site

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: sakai nobuyuki
• Source(s) of Monetary Support: Bolt Medical CO.LTD