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Headache After Coil Embolization for Unruptured Intracranial Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359252
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Headache Aneurysm Endovascular Procedures Procedure: non-stent assisted coiling Procedure: stent assisted coiling Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-stent assisted coiling of unruptured intracranial aneurysms stent assisted coiling of unruptured intracranial aneurysms
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: non-stent assisted coiling
patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
Procedure: non-stent assisted coiling
non-stent assisted coiling of unruptured intracranial aneurysm

Experimental: stent assisted coiling
patients treated with stent assisted coiling of unruptured intracranial aneurysm
Procedure: stent assisted coiling
stent assisted coiling of unruptured intracranial aneurysm




Primary Outcome Measures :
  1. severity of headache after coil embolization between 2 arms [ Time Frame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days ]
    check change of severity of headache after coil embolization between 2 arms


Secondary Outcome Measures :
  1. Duration of headache after coiling embolization after intervention [ Time Frame: Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months ]
    check duration of headache after coil embolization

  2. characteristics of headache after coiling embolization between 2 arms [ Time Frame: prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days ]
    identify relationship between headache location and treated aneurysm or deployed stent



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359252


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: O Kwon, M.D., Ph.D. Seoul National University Bundang Hospital
Publications of Results:
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03359252    
Other Study ID Numbers: B-1710/424-304
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
coil embolization
headache
stent
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Headache
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases