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Bare Platinum Coils Versus Second-generation Hydrocoils

Primary Purpose

Aneurysm, Ruptured, Intracranial Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Coil embolization
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm, Ruptured focused on measuring aneurysms, embolization, rupture

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungnam National University Sejong HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Second-generation hydrogel coil group

Bare platinum coil group

Arm Description

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

Treatment using bare metal coil only for ruptured cerebral aneurysms

Outcomes

Primary Outcome Measures

recurrence rate after treatment
recurrence rate at 12 months after coil embolization

Secondary Outcome Measures

Rates of thromboembolic and hemorrhagic complications
Rates of thromboembolic and hemorrhagic complications
Rate of periprocedural complications
Rate of periprocedural complications
Assessment of clinical outcomes using modified Rankin Scale scores
Modified Rankin Scale scores (0-6, higher scores mean a worse outcome)

Full Information

First Posted
July 23, 2021
Last Updated
October 23, 2022
Sponsor
Seoul National University Hospital
Collaborators
Pusan National University Yangsan Hospital, Chungnam National University Sejong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04988503
Brief Title
Bare Platinum Coils Versus Second-generation Hydrocoils
Official Title
Bare Platinum Coils Versus Second-generation Hydrocoils for the Endovascular Treatment of Ruptured Intracranial Aneurysms: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Pusan National University Yangsan Hospital, Chungnam National University Sejong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm, Ruptured, Intracranial Aneurysm
Keywords
aneurysms, embolization, rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
bare platinum coils group versus second-generation hydrogel coil group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Second-generation hydrogel coil group
Arm Type
Experimental
Arm Description
Treatment using second-generation hydrogel coils (had to constitute > 50% of the total coil length) for ruptured cerebral aneurysms
Arm Title
Bare platinum coil group
Arm Type
Active Comparator
Arm Description
Treatment using bare metal coil only for ruptured cerebral aneurysms
Intervention Type
Device
Intervention Name(s)
Coil embolization
Intervention Description
coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils
Primary Outcome Measure Information:
Title
recurrence rate after treatment
Description
recurrence rate at 12 months after coil embolization
Time Frame
during 12 months after coil embolization
Secondary Outcome Measure Information:
Title
Rates of thromboembolic and hemorrhagic complications
Description
Rates of thromboembolic and hemorrhagic complications
Time Frame
during 12 months after coil embolization
Title
Rate of periprocedural complications
Description
Rate of periprocedural complications
Time Frame
within 30 days after coil embolization
Title
Assessment of clinical outcomes using modified Rankin Scale scores
Description
Modified Rankin Scale scores (0-6, higher scores mean a worse outcome)
Time Frame
during 12 months after coil embolization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Pil Ban
Phone
81-31-787-7175
Email
neurosurgeryban@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
O-Ki Kwon
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Sejong Hospital
City
Sejong
State/Province
Chungnam
ZIP/Postal Code
30099
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Soo Byoun, MD
Phone
82-44-995-4950
Email
prettypig9@hanmail.net
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Hyeun Kim, MD
Phone
82-55-360-2011
Email
mole83@hanmail.net
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Pil Ban, MD
Phone
82-31-787-7175
Email
neurosurgeryban@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Bare Platinum Coils Versus Second-generation Hydrocoils

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