Safety and efficacy of the stabilizer device using in endovascular therapy

Not Applicable

• Conditions: cerebral aneurysm, cerebral artery stenosis

• Registration Number: JPRN-jRCT2052220056
• Lead Sponsor: Sakai Nobuyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness assessment:Successful rate of treatment procedure<br>Safety evaluation:Rate of serious adverse events within 7 days of treatment

Secondary Outcome Measures

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