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Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Primary Purpose

Headache, Aneurysm, Endovascular Procedures

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-stent assisted coiling
stent assisted coiling
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache focused on measuring coil embolization, headache, stent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with unruptured intracranial aneurysms
  • patients over 20 years old
  • patients who can communicate with each other
  • patients who agreed to this study (with informed consent)

Exclusion Criteria:

  • patients with recurrent aneurysms after coiling or clipping
  • patients with allergic reaction to antiplatelets
  • patients with high risks of hemorrhage
  • patients with coagulopathy
  • patients with thrombocytopenia (<100,000/mm3)
  • patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase)
  • patients with renal disease (> 2mg/dL of serum creatinine)\
  • patients with uncontrolled heart failure or angina
  • patients with malignant tumor
  • pregnant patients
  • patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor)
  • Patients who are determined to be disqualified by researchers

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

non-stent assisted coiling

stent assisted coiling

Arm Description

patients treated with non-stent assisted coiling of unruptured intracranial aneurysms

patients treated with stent assisted coiling of unruptured intracranial aneurysm

Outcomes

Primary Outcome Measures

severity of headache after coil embolization between 2 arms
check change of severity of headache after coil embolization between 2 arms

Secondary Outcome Measures

Duration of headache after coiling embolization after intervention
check duration of headache after coil embolization
characteristics of headache after coiling embolization between 2 arms
identify relationship between headache location and treated aneurysm or deployed stent

Full Information

First Posted
November 27, 2017
Last Updated
October 23, 2022
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03359252
Brief Title
Headache After Coil Embolization for Unruptured Intracranial Aneurysms
Official Title
Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

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

5. Study Description

Brief Summary
Perform a prospective cohort study to compare the incidence and severity of headache between non-stent assisted coiling and stent assisted coiling of unruptured intracranial aneurysms.
Detailed Description
severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Aneurysm, Endovascular Procedures
Keywords
coil embolization, headache, stent

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-stent assisted coiling
Arm Type
Active Comparator
Arm Description
patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
Arm Title
stent assisted coiling
Arm Type
Experimental
Arm Description
patients treated with stent assisted coiling of unruptured intracranial aneurysm
Intervention Type
Procedure
Intervention Name(s)
non-stent assisted coiling
Intervention Description
non-stent assisted coiling of unruptured intracranial aneurysm
Intervention Type
Procedure
Intervention Name(s)
stent assisted coiling
Intervention Description
stent assisted coiling of unruptured intracranial aneurysm
Primary Outcome Measure Information:
Title
severity of headache after coil embolization between 2 arms
Description
check change of severity of headache after coil embolization between 2 arms
Time Frame
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days
Secondary Outcome Measure Information:
Title
Duration of headache after coiling embolization after intervention
Description
check duration of headache after coil embolization
Time Frame
Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months
Title
characteristics of headache after coiling embolization between 2 arms
Description
identify relationship between headache location and treated aneurysm or deployed stent
Time Frame
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with unruptured intracranial aneurysms patients over 20 years old patients who can communicate with each other patients who agreed to this study (with informed consent) Exclusion Criteria: patients with recurrent aneurysms after coiling or clipping patients with allergic reaction to antiplatelets patients with high risks of hemorrhage patients with coagulopathy patients with thrombocytopenia (<100,000/mm3) patients with liver disease (> 100 of aspartate aminotransferase or alanine aminotransferase) patients with renal disease (> 2mg/dL of serum creatinine)\ patients with uncontrolled heart failure or angina patients with malignant tumor pregnant patients patients with past history that may associated with headache, including subarachnoid hemorrhage, head trauma, intracerebral hemorrhage, trigeminal neuralgia, arteriovenous malformation, brain tumor) Patients who are determined to be disqualified by researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
O Kwon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12867109
Citation
Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
Results Reference
result
PubMed Identifier
20671254
Citation
Sonobe M, Yamazaki T, Yonekura M, Kikuchi H. Small unruptured intracranial aneurysm verification study: SUAVe study, Japan. Stroke. 2010 Sep;41(9):1969-77. doi: 10.1161/STROKEAHA.110.585059. Epub 2010 Jul 29.
Results Reference
result
PubMed Identifier
23771276
Citation
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
Results Reference
result
PubMed Identifier
27991669
Citation
Zhang L, Wu X, Di H, Feng T, Wang Y, Wang J, Cao X, Li B, Liu R, Yu S. Characteristics of Headache After an Intracranial Endovascular Procedure: A Prospective Observational Study. Headache. 2017 Mar;57(3):391-399. doi: 10.1111/head.13006. Epub 2016 Dec 19.
Results Reference
result
PubMed Identifier
24801821
Citation
Choi KS, Lee JH, Yi HJ, Chun HJ, Lee YJ, Kim DW. Incidence and risk factors of postoperative headache after endovascular coil embolization of unruptured intracranial aneurysms. Acta Neurochir (Wien). 2014 Jul;156(7):1281-7. doi: 10.1007/s00701-014-2095-8. Epub 2014 May 7. Erratum In: Acta Neurochir (Wien). 2014 Sep;156(9):1829.
Results Reference
result

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Headache After Coil Embolization for Unruptured Intracranial Aneurysms

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