Safety and Efficacy of Cerebral Aneurysm Embolization Devices -Observational Study-

Safety and Efficacy of Cerebral Aneurysm Embolization Devices -Observational Study- - Safety and Efficacy of Cerebral Aneurysm Embolization Devices -Observational Study-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048475

Enrollment

130

Registered

2022-07-26

Start date

2022-07-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral aneurysm Cerebral arteriovenous malformation Cerebral arteriovenous fistula

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male and female patients between the ages of 18 and 80 2) Patients undergoing endovascular treatment with coils for intracranial arterial lesions (aneurysm, arteriovenous malformation, arteriovenous fistula) 3) Patients in whom more than 50% of coils used for endovascular treatment were i-ED coils 4) Patients who have given written consent to participate in this study from the research subjects themselves

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1) Aneurysm cases Reopening rate at 12 months of treatment 2) Arteriovenous malformation and arteriovenous fistula Reoperation rate at 12 months of treatment	—

Secondary

Measure	Time frame
1) In addition to the evaluation of the following items at each time point, the transition and amount of change up to 12 months after treatment will be evaluated. NIHSS, modified Rankin Scale (mRS), re-treatment or not, Raymond Scale (only for aneurysm cases), loss of venous perfusion (only for arteriovenous fistula cases) 2) Success rate of the procedure 3) Percentage of cases with >50% reduction in size (volume) of arteriovenous malformation immediately after treatment	—

Measure

Time frame

1) In addition to the evaluation of the following items at each time point, the transition and amount of change up to 12 months after treatment will be evaluated. NIHSS, modified Rankin Scale (mRS), re-treatment or not, Raymond Scale (only for aneurysm cases), loss of venous perfusion (only for arteriovenous fistula cases) 2) Success rate of the procedure 3) Percentage of cases with >50% reduction in size (volume) of arteriovenous malformation immediately after treatment

—

Countries

Japan

Contacts

Public ContactMakoto Arai

Nouvelle Place Inc. -

i-ED@n-place.co.jp03-6680-2525

Outcome results