Headache After Coil Embolization for Unruptured Intracranial Aneurysms

NCT ID: NCT03359252

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2022-10-21

Brief Summary

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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

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severity of headache - assess with visual analogue scale characteristics of headache after stent deployment or simple coiling Duration of headache after intervention

Conditions

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Headache Aneurysm Endovascular Procedures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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non-stent assisted coiling

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

Group Type ACTIVE_COMPARATOR

non-stent assisted coiling

Intervention Type PROCEDURE

non-stent assisted coiling of unruptured intracranial aneurysm

stent assisted coiling

patients treated with stent assisted coiling of unruptured intracranial aneurysm

Group Type EXPERIMENTAL

stent assisted coiling

Intervention Type PROCEDURE

stent assisted coiling of unruptured intracranial aneurysm

Interventions

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non-stent assisted coiling

non-stent assisted coiling of unruptured intracranial aneurysm

Intervention Type PROCEDURE

stent assisted coiling

stent assisted coiling of unruptured intracranial aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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O Kwon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 12867109 (View on PubMed)

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.

Reference Type RESULT
PMID: 20671254 (View on PubMed)

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.

Reference Type RESULT
PMID: 23771276 (View on PubMed)

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.

Reference Type RESULT
PMID: 27991669 (View on PubMed)

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.

Reference Type RESULT
PMID: 24801821 (View on PubMed)

Other Identifiers

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B-1710/424-304

Identifier Type: -

Identifier Source: org_study_id

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