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Completed

NCT Number: NCT03359252

Headache After Coil Embolization for Unruptured Intracranial Aneurysms

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.

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Key information

Conditions

Headache Aneurysm Cardiovascular Diseases Endovascular Procedures Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-stent assisted coiling

Procedure

non-stent assisted coiling of unruptured intracranial aneurysm

stent assisted coiling

Procedure

stent assisted coiling of unruptured intracranial aneurysm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2017
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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