Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

NCT05796986 | Recruiting

• 1 other identifier: Soh-Med-23-03-02MD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Wide Neck Saccular Cerebral Aneurysms

Outcome Measures

Primary Outcomes (1)

• efficacy of procedure

  degree of aneurysm occlusion classifeid by Raymond Roy classification

  1 year

Study Arms (1)

Wide neck saccular cerebral aneurysms patients

EXPERIMENTAL

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

Interventions

Endovascular procedure of treatment of wide neck saccular cerebral aneurysm PROCEDURE

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

Wide neck saccular cerebral aneurysms patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 31964292 BACKGROUND

• 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.

  PMID: 30110521 BACKGROUND

• 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.

  PMID: 21519497 BACKGROUND

• 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.

  PMID: 23798560 BACKGROUND

Central Study Contacts

Mohmed A Awesh, assistant lecturer

CONTACT

01068368550; mohamed.ayman@med.sohag.edu.eg

Mohamed A Abdelaal, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of neurosurgery

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 4, 2023
• Study Start: January 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

EG (1)