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RecruitingNCT05796986Updated Apr 16, 2024

Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

An interventional study of Endovascular procedure of treatment of wide neck saccular cerebral aneurysm in Wide Neck Saccular Cerebral Aneurysms, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2022, registered Mar 2023).
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Sex
All
01

Study 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.

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Conditions studied

  • Wide Neck Saccular Cerebral Aneurysms
03

In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.

This study's planned enrollment of 40 is below the median of 115 across 206 interventional studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Wide neck saccular cerebral aneurysms patients

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

Interventions

  • ProcedureEndovascular 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

06

What researchers measure

Primary outcomes

  1. efficacy of procedure

    degree of aneurysm occlusion classifeid by Raymond Roy classification

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Egypt
    • Magdy M Amin, Professor · Contact
    Recruiting
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References and documents

Publications

  • Maher M, Schweizer TA, Macdonald RL. Treatment of Spontaneous Subarachnoid Hemorrhage: Guidelines and Gaps. Stroke. 2020 Apr;51(4):1326-1332. doi: 10.1161/STROKEAHA.119.025997. Epub 2020 Jan 22. No abstract available. PubMed 31964292 ↗
  • Lindgren A, Vergouwen MD, van der Schaaf I, Algra A, Wermer M, Clarke MJ, Rinkel GJ. Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage. Cochrane Database Syst Rev. 2018 Aug 15;8(8):CD003085. doi: 10.1002/14651858.CD003085.pub3. PubMed 30110521 ↗
  • Kim JW, Park YS. Endovascular treatment of wide-necked intracranial aneurysms : techniques and outcomes in 15 patients. J Korean Neurosurg Soc. 2011 Feb;49(2):97-101. doi: 10.3340/jkns.2011.49.2.97. Epub 2011 Feb 28. PubMed 21519497 ↗
  • Pierot L, Wakhloo AK. Endovascular treatment of intracranial aneurysms: current status. Stroke. 2013 Jul;44(7):2046-54. doi: 10.1161/STROKEAHA.113.000733. No abstract available. PubMed 23798560 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05796986
Lead sponsor
Sohag University
Responsible party
Mohamed Ayman Mohamed (Assistant lecturer of neurosurgery, Sohag University) — Principal investigator
First posted
Apr 4, 2023
Start date
Jan 1, 2022
Primary completion
Oct 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Apr 16, 2024

Study contacts

Mohmed A Awesh, assistant lecturer
Contact
mohamed.ayman@med.sohag.edu.eg
01068368550
Mohamed A Abdelaal, Professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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