Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

Sohag University

Status: Enrolling

Conditions: Wide Neck Saccular Cerebral Aneurysms

Treatments: Procedure: Endovascular procedure of treatment of wide neck saccular cerebral aneurysm

Study type: Interventional

Funder types: Other

Identifiers

NCT05796986

Soh-Med-23-03-02MD

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Wide neck saccular cerebral aneurysms patients

Experimental group

Treatment:

Procedure: Endovascular procedure of treatment of wide neck saccular cerebral aneurysm