Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Primary Purpose
Wide Neck Saccular Cerebral Aneurysms
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endovascular procedure of treatment of wide neck saccular cerebral aneurysm
Sponsored by
About this trial
This is an interventional treatment trial for Wide Neck Saccular Cerebral Aneurysms
Eligibility Criteria
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
Sites / Locations
- Sohag University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wide neck saccular cerebral aneurysms patients
Arm Description
Outcomes
Primary Outcome Measures
efficacy of procedure
degree of aneurysm occlusion classifeid by Raymond Roy classification
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05796986
Brief Title
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Official Title
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide Neck Saccular Cerebral Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wide neck saccular cerebral aneurysms patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Endovascular procedure of treatment of wide neck saccular cerebral aneurysm
Intervention Description
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
Primary Outcome Measure Information:
Title
efficacy of procedure
Description
degree of aneurysm occlusion classifeid by Raymond Roy classification
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohmed A Awesh, assistant lecturer
Phone
01068368550
Email
mohamed.ayman@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Abdelaal, Professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
31964292
Citation
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.
Results Reference
background
PubMed Identifier
30110521
Citation
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.
Results Reference
background
PubMed Identifier
21519497
Citation
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.
Results Reference
background
PubMed Identifier
23798560
Citation
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.
Results Reference
background
Learn more about this trial
Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms
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