Safety and efficacy of the stabilizer device using in endovascular therapy

JRCT ID: jRCT2052220056

Registered date:22/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cerebral aneurysm, cerebral artery stenosis
• Date of first enrollment: 21/07/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Deliver therapeutic equipment to lesions using unapproved devices during cerebrovascular treatment

Outcome(s)

Primary Outcome

Effectiveness assessment:Successful rate of treatment procedure
Safety evaluation:Rate of serious adverse events within 7 days of treatment

Secondary Outcome

1, Rate of serious adverse events within 7 days of treatment
2. Hemorrhagic stroke requiring treatment within 7 days of treatment or until discharge
3, Ischemic stroke requiring treatment within 7 days of treatment or until discharge
4, Arterial dissection requiring treatment that cannot be denied to be related to the investigational device
5, Symptomatic vasospasm that cannot be denied to be related to the investigational device
6, Other serious adverse events that cannot be denied to be related to the investigational device

Key inclusion & exclusion criteria

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

Include criteria

1 Patients aged between 20years and 80years old at the time of concent acquisition
2 modified Rankin Scale is 3 or less
3 Patients with cerebral aneurysm or cerebral artery stenosis who cannot deliver therapeutic medical devices by conventional methods including replacement during endovascular treatment
4 patients who concented to the study in writing.

Exclude criteria

1.Heparin cannot be administered for medical reasons
2.It is difficult to follow up 7 days after surgery
3.Have a history of severe contrast agent allergies
4.The following patients who are contraindicated in the clinical trial device summary
(1) Patients with allergies to metals contained in the investigational equipment The following patients who are contraindicated in the investigational equipment summary
(2) Patients with carotid artery dissection, carotid cervical obstruction or vasculitis
5.Participating in other clinical trials
6.Pregnant or breastfeeding, or unwilling to use contraception during the trial (female only)
7.In addition, the investigator or the investigator has determined that it is inappropriate for conducting this clinical trial.

Related Information

• Primary Sponsor: Sakai Nobuyuki
• Secondary Sponsor: Sakai Chiaki,Bolt Medical CO.LTD
• Secondary ID(s): Nil known