Headache After Coil Embolization for Unruptured Intracranial Aneurysms

October 23, 2022 updated by: Seoul National University Hospital

Comparison of Headache After Coil Embolization for Unruptured Intracranial Aneurysms (Standard Versus Stent-assisted): A Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measure the duration of time from when a headache occurs to when it disappears, assessed up to 3 months
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
prior to intervention / immediate after procedures / postoperative days 3, 7, 14, 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: O Kwon, M.D., Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Actual)

October 21, 2022

Study Completion (Actual)

October 21, 2022

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 23, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1710/424-304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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