Bare Platinum Coils Versus Second-generation Hydrocoils

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04988503
• Collaborator: Pusan National University Yangsan Hospital (Other), Chungnam National University Sejong Hospital (Other)
• Enrollment: 118
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site: 39.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysm, Ruptured; Intracranial Aneurysm	Device: Coil embolization	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: bare platinum coils group versus second-generation hydrogel coil groupbare platinum coils group versus second-generation hydrogel coil group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
• Actual Study Start Date: Aug 30, 2021
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Second-generation hydrogel coil group Treatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms	Device: Coil embolization; coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils
Active Comparator: Bare platinum coil group Treatment using bare metal coil only for ruptured cerebral aneurysms	Device: Coil embolization; coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Outcome Measures

Primary Outcome Measures

1. recurrence rate after treatment [during 12 months after coil embolization]

   recurrence rate at 12 months after coil embolization

Secondary Outcome Measures

1. Rates of thromboembolic and hemorrhagic complications [during 12 months after coil embolization]

   Rates of thromboembolic and hemorrhagic complications

2. Rate of periprocedural complications [within 30 days after coil embolization]

   Rate of periprocedural complications

3. Assessment of clinical outcomes using modified Rankin Scale scores [during 12 months after coil embolization]

   Modified Rankin Scale scores (0-6, higher scores mean a worse outcome)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Sejong Hospital	Sejong	Chungnam	Korea, Republic of	30099
2	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do	Korea, Republic of	50612
3	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Hospital
• Pusan National University Yangsan Hospital
• Chungnam National University Sejong Hospital

Investigators

• Principal Investigator: O-Ki Kwon, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04988503
• Other Study ID Numbers: B-2012/652-002
• First Posted: Aug 3, 2021
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seoul National University Hospital: aneurysms; embolization; rupture
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm; Aneurysm, Ruptured

Study Results

No Results Posted as of Jul 7, 2022