Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05796986
Collaborator
(none)
40
1
1
26
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endovascular procedure of treatment of wide neck saccular cerebral aneurysm
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Wide neck saccular cerebral aneurysms patients

Procedure: Endovascular procedure of treatment of wide neck saccular cerebral aneurysm
Endovascular different modalities for occlusion of wide neck saccular cerebral aneurysms include stent assisted coiling or balloon assisted coiling or flow diverter or 3D coiling

Outcome Measures

Primary Outcome Measures

  1. efficacy of procedure [1 year]

    degree of aneurysm occlusion classifeid by Raymond Roy classification

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Ayman Mohamed, Assistant lecturer of neurosurgery, Sohag University
ClinicalTrials.gov Identifier:
NCT05796986
Other Study ID Numbers:
  • Soh-Med-23-03-02MD
First Posted:
Apr 4, 2023
Last Update Posted:
Apr 4, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2023