Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

• Conditions: Stent Embolisation
• Interventions: Procedure: stent assisted embolization

• Registration Number: NCT01702584
• Lead Sponsor: Kobe City General Hospital

Brief Summary

Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

Detailed Description

To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Primary Completion: 2018-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• stent assisted embolization of intracranial aneurysm
• 20 or more year old

Exclusion Criteria

• not determined

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stent assisted embolization	stent assisted embolization	stent assisted embolization of intracranial aneurysm

Primary Outcome Measures

Name	Time	Method
any death, stroke and major hemorrhagic event	2 years after treatment	any death, stroke and major hemorrhagic event within 2 years after treatment

Secondary Outcome Measures

Name	Time	Method
any adverse event	2 years	1. death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment; 2. any change of anti-thrombotic therapy within 2years after treatment; 3. recanalization or re-treatment within 2years after treatment; 4. stent stenosis or occlusion within 2years after treatment; 5. any adverse event within 2years after treatment

Trial Locations

Locations (1)

Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Hyogo, Japan