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Headache After Coil Embolization for Unruptured Intracranial Aneurysms

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Aneurysm
Headache
Endovascular Procedures

Treatments

Procedure: non-stent assisted coiling
Procedure: stent assisted coiling

Study type

Interventional

Funder types

Other

Identifiers

NCT03359252
B-1710/424-304

Details and patient eligibility

About

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.

Full description

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

Enrollment

190 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

190 participants in 2 patient groups

non-stent assisted coiling
Active Comparator group
Description:
patients treated with non-stent assisted coiling of unruptured intracranial aneurysms
Treatment:
Procedure: non-stent assisted coiling
stent assisted coiling
Experimental group
Description:
patients treated with stent assisted coiling of unruptured intracranial aneurysm
Treatment:
Procedure: stent assisted coiling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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