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NCT04988503 Clinical Trial

Bare Platinum Coils Versus Second-generation Hydrocoils

Intracranial Aneurysm Clinical Trial

Official title:
Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04988503
Other study ID # B-2012/652-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 30, 2021
Est. completion date December 31, 2025

Study information
Verified date January 2024
Source Seoul National University Hospital
Contact Seung Pil Ban
Phone 81-31-787-7175
Email neurosurgeryban@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of clinical and radiological outcomes between bare platinum coil group and second-generation hydrogel coils for treatment of ruptured intracranial aneurysms.

Description:

The investigators aimed to analyze whether the use of second-generation hydrogel coils for the treatment of ruptured intracranial aneurysms improves clinical and angiographic outcomes compared with the use of bare platinum coils.

Recruitment information / eligibility
Status Recruiting
Enrollment 118
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 19 year old or older - untreated ruptured intracranial aneurysms with an anatomy such that endovascular treatment with either bare platinum or second-generation hydrogel coils was considered feasible. - person who agreed to study Exclusion Criteria: - contrast allgery (+) - combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases) - ineligible for coil embolization

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Coil embolization
coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Locations
Country Name City State
Korea, Republic of Chungnam National University Sejong Hospital Sejong Chungnam
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do

Sponsors (3)
Lead Sponsor Collaborator
Seoul National University Hospital Chungnam National University Sejong Hospital, Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence rate after treatment recurrence rate at 12 months after coil embolization during 12 months after coil embolization
Secondary Rates of thromboembolic and hemorrhagic complications Rates of thromboembolic and hemorrhagic complications during 12 months after coil embolization
Secondary Rate of periprocedural complications Rate of periprocedural complications within 30 days after coil embolization
Secondary Assessment of clinical outcomes using modified Rankin Scale scores Modified Rankin Scale scores (0-6, higher scores mean a worse outcome) during 12 months after coil embolization
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