Bare Platinum Coils Versus Second-generation Hydrocoils

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

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

Study Overview

• Status: Terminated
• Conditions: Intracranial Aneurysm; Aneurysm, Ruptured
• Intervention / Treatment: Device: Coil embolization

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Chungnam
    • Sejong, Chungnam, Korea, Republic of, 30099
      • Chungnam National University Sejong Hospital
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
any recurrence rate after treatment	any recurrence rate at 12 months after coil embolization	during 12 months after coil embolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of retreatment during 12 months follow-up period	rate of retreatment during 12 months follow-up period	rate of retreatment during 12 months follow-up period
packing density (%) after coil embolization	packing density (%) after coil embolization	packing density (%) after coil embolization
good clinical outcome (mRS score ≤ 2) at 12-month follow-up period	good clinical outcome (mRS score ≤ 2) at 12-month follow-up period	good clinical outcome (mRS score ≤ 2) at 12-month follow-up period
rate of ventriculoperitoneal shunt during 12-month follow-up period	rate of ventriculoperitoneal shunt during 12-month follow-up period	rate of ventriculoperitoneal shunt during 12-month follow-up period
Procedural complication	Procedural complication	during coil embolization
delayed cerebral ischemia during 12-month follow-up period	delayed cerebral ischemia during 12-month follow-up period	delayed cerebral ischemia during 12-month follow-up period
coil's ease of manipulation	coil's ease of manipulation	during coil embolization

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Pusan National University Yangsan Hospital; Chungnam National University Sejong Hospital
• Investigators: Principal Investigator: O-Ki Kwon, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: embolization; aneurysms; rupture
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Aneurysm, Ruptured
• Other Study ID Numbers: B-2012/652-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No