Bare Platinum Coils Versus Second-generation Hydrocoils

NCT04988503 | Terminated DMC

• 1 other identifier: B-2012/652-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Aneurysm, Ruptured; Intracranial Aneurysm

Keywords

aneurysms; embolization; rupture

Outcome Measures

Primary Outcomes (1)

• any recurrence rate after treatment

  any recurrence rate at 12 months after coil embolization

  during 12 months after coil embolization

Secondary Outcomes (7)

• 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

• Procedural complication

  during coil embolization

• delayed cerebral ischemia during 12-month follow-up period

  delayed cerebral ischemia during 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

Study Arms (2)

Second-generation hydrogel coil group

EXPERIMENTAL

Treatment using second-generation hydrogel coils (had to constitute \> 50% of the total coil length) for ruptured cerebral aneurysms

Device: Coil embolization

Bare platinum coil group

ACTIVE COMPARATOR

Treatment using bare metal coil only for ruptured cerebral aneurysms

Device: Coil embolization

Interventions

Coil embolization DEVICE

coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils

Bare platinum coil group; Second-generation hydrogel coil group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contrast allgery (+)
• combined other intracranial lesions (tumor, moyamoya disease, cerebral vascular diseases)
• ineligible for coil embolization

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Pusan National University Yangsan Hospital: collaborator
• Chungnam National University Sejong Hospital: collaborator

Study Sites (3)

Chungnam National University Sejong Hospital

Sejong, Chungcheongnam-do, 30099, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

MeSH Terms

Conditions

Aneurysm, Ruptured; Intracranial Aneurysm; Aneurysm; Rupture

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries

Study Officials

• O-Ki Kwon

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: bare platinum coils group versus second-generation hydrogel coil group

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 3, 2021
• Study Start: August 30, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)