Safety and Efficacy of Cerebral Aneurysm Embolization Devices -Observational Study

Not Applicable

• Conditions: cerebral aneurysm Cerebral arteriovenous malformation Cerebral arteriovenous fistula

• Registration Number: JPRN-UMIN000048475
• Lead Sponsor: Kaneka Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-26
• Study Completion: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with significant stenosis (>50%) in the parent extracranial or intracranial artery proximal to the target aneurysm 2) Patients with target aneurysm in the anterior circulation of the proximal portion of the subxiphoid artery 3) Patients who need to leave the neck to maintain blood flow in the bifurcation or branch in the treatment of a target aneurysm 4) Patients undergoing coiling or stenting of non-target lesions within 30 days prior to treatment of the target lesion 5) Patients with multiple aneurysms and treatment of other aneurysms within 30 days of treatment of the target aneurysm under investigation 6) Patients undergoing flow diverter implantation for treatment of target aneurysm to be studied 7) Patients with a Hunt and Hess score of 3 or higher or a modified Rankin Scale (mRS) score of 4 or higher 8) Patients with contraindications to CT or MRI 9) Patients with contraindications to angiography

Study & Design

• Study Type: Observational
• Study Design: Not specified