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Clinical Trials/NCT05796986
NCT05796986
Recruiting
Not Applicable

Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

Sohag University1 site in 1 country40 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wide Neck Saccular Cerebral Aneurysms
Sponsor
Sohag University
Enrollment
40
Locations
1
Primary Endpoint
efficacy of procedure
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Intracranial aneurysm (IA) is a cerebrovascular disorder in which the weakness of a cerebral artery wall causes a localized dilation of the blood vessel. Intracranial aneurysm can develop and rupture, and about 85% of spontaneous subarachnoid hemorrhage (SAH) cases are caused by the rupture of Intracerebral aneurysm.

Two treatments are available globally: microsurgical clipping and endovascular treatment.

Endovascular treatment of Intracerebral aneurysms using detachable platinum coils ( was introduced in 1990 by Guido Guglielmi, an Italian neurosurgeon ) of different shapes and sizes are deposited into the aneurysm through a microcatheter, which reduces the blood flow and induces thrombus formation .

Wide neck aneurysm defined by neck diameter greater than 4 mm or dome-to-neck ratio less than 2 Despite advances in endovascular techniques , the treatment of wide-necked aneurysms remains problematic . Endovascular treatment of intracranial aneurysms is associated with lower morbidity and mortality rates and faster recovery compared with traditional microsurgical clipping.

In wide-necked Intracerebral aneurysms, complete coil embolization is often technically difficult owing to the risks of distal coil migration or coil impingement on the parent vessel .

Complete coil embolization using a single microcatheter without a supporting device in cases of wide-necked Intracerebral aneurysm is technically difficult. Total occlusion rates have increased recently as a result of the advancement of supporting devices These may include balloon remodeling, use of three-dimensional (3D) coils (Russian Doll Technique), combined use of stents and coils (Stent assisted coiling), flow diverters, use of intrasaccular flow disruption (like WEB), Double catheter Technique or combined extra- and intrasaccular devices.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Ayman Mohamed

Assistant lecturer of neurosurgery

Sohag University

Eligibility Criteria

Inclusion Criteria

  • All patients of spontaneous subarachnoid haemorrhage due to ruptured wide neck saccular cerebral aneurysms
  • unruptured Denovo wide neck saccular cerebral aneurysms

Exclusion Criteria

  • other forms of cerebral aneurysms rather than saccular type : fusiform and dissecting aneurysms
  • complex aneurysms : giant and thrombosed aneyrsms
  • any spontaneous subarachnoid haemorrhage with world fedriation of neurosurgery societies (WFNS) Grade 4\&5
  • Any patient unfit for general anesethia or has serious renal impairment

Outcomes

Primary Outcomes

efficacy of procedure

Time Frame: 1 year

degree of aneurysm occlusion classifeid by Raymond Roy classification

Study Sites (1)

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