Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

Stent Embolisation Clinical Trial

Official title:

Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01702584
• Other study ID #: TRIBRAIN1204
• Secondary ID: UMIN000010405
• Status: Recruiting
• Start date: September 2012
• Est. completion date: March 2021

Study information

• Verified date: September 2020
• Source: Kobe City General Hospital
• Contact: Nobuyuki Sakai, MD, DMSc
• Phone: 81783024321
• Email: n.sakai[@]siren.ocn.ne.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2021
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• stent assisted embolization of intracranial aneurysm

• 20 or more year old

Exclusion Criteria:

• not determined

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Stent Embolisation

Intervention

Procedure:
• stent assisted embolization
stent assisted embolization and anti-thrombotic management

Locations

Country	Name	City	State
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Kobe City General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any death, stroke and major hemorrhagic event	any death, stroke and major hemorrhagic event within 2 years after treatment	2 years after treatment
Secondary	any adverse event	death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment; any change of anti-thrombotic therapy within 2years after treatment; recanalization or re-treatment within 2years after treatment; stent stenosis or occlusion within 2years after treatment; any adverse event within 2years after treatment	2 years