JPRN-jRCT2052220056
Active, not recruiting
未知
Safety and efficacy of the stabilizer device using in endovascular therapy - SD-01 Trial
Sakai Nobuyuki0 sites30 target enrollmentJune 22, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sakai Nobuyuki
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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