Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

NCT ID: NCT05796986

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Wide Neck Saccular Cerebral Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wide neck saccular cerebral aneurysms patients

Group Type EXPERIMENTAL

Endovascular procedure of treatment of wide neck saccular cerebral aneurysm

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ayman Mohamed

Assistant lecturer of neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohmed A Awesh, assistant lecturer

Role: CONTACT

01068368550

Mohamed A Abdelaal, Professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, Professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31964292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30110521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21519497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23798560 (View on PubMed)

Other Identifiers

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Soh-Med-23-03-02MD

Identifier Type: -

Identifier Source: org_study_id

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