Current Treatment Modalities for Wide Necked Intracranial Aneurysms
Primary Purpose
Brain Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aneurysm clipping
Sponsored by
About this trial
This is an interventional treatment trial for Brain Aneurysm focused on measuring wide necked intracranial aneurysms
Eligibility Criteria
Inclusion Criteria:
• Patients who undergo surgical clipping or any endovascular techniques used in treatment of wide-necked intracranial aneurysms. Wide-necked aneurysms are defined as aneurysms with a fundus-to-neck ratio of less than 2 or a neck diameter of 14 mm.
Exclusion Criteria:
- patients with narrow-necked intracranial aneurysms
- patients who are unfit for any neurosurgical interventions.
- patients who had artery aneurysm and vascular malformation due to some trauma.
Sites / Locations
- Faculty of medicine
Outcomes
Primary Outcome Measures
Independent clinical outcome changes
The changes in clinical condition of the patients will be assessed before and after treatment using modified Rankin scale, as the scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
Postoperative angiographic occlusion rate changes
The changes in postoperative angiographic occlusion rate will be assessed in different time frame using CT angiography or conventional angiography (if CT angiography is not conclusive)
Secondary Outcome Measures
incidence of aneurysm rupture
as complication of treatment
incidence of cerebral vasospasm
as complication of treatment
Mortality rate
as a result of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852680
Brief Title
Current Treatment Modalities for Wide Necked Intracranial Aneurysms
Official Title
Current Treatment Modalities for Wide Necked Intracranial Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Give an effective treatment for intracranial wide necked aneurysm and can detect the best method could be used.
Improve the outcome of these patients and decease rate of recurrence and complications.
Detailed Description
The prevalence of intracranial aneurysms in the adult population is estimated to be around 2 %. Most remain asymptomatic, but there is a risk of rupture of 1.2 % per year, and this risk increases in line with the diameter of the aneurysm. If rupture occurs, subarachnoid hemorrhage and its associated acute complications are responsible for high mortality (between 30 and 67 %) and morbidity (between 15 and 30 %).
Coil embolization of intracranial aneurysms has made remarkable technological progress since the International Subarachnoid Aneurysm Trial (ISAT) data were released in 2005. However, wide-necked aneurysms remain a great challenge to be treated via the endovascular means, as they are associated with a significantly greater incidence of adverse events when compared with narrow-necked ones.
Acutely ruptured wide-necked intracranial aneurysms pose technical challenges to the treating physician; thus, multiple endovascular techniques have been described to treat these lesions, including balloon-assisted coil placement, double microcatheter technique, and microcatheter assisted coil placement. However, the use of these techniques can sometimes be limited, owing to the lack of permanent support for the coil mass inside the aneurysm sac, which may lead to coil prolapse or migration after the procedure, especially for wide-necked aneurysms (dome-to-neck ratio is less than 1) or tiny aneurysms (3 mm). Therefore, surgical clipping is preferred for acutely ruptured wide-necked intracranial aneurysms in most institutions. Surgery, however, may also be challenging in some of these lesions, since clips may slip, and surgical access may be limited because of the swelling of the brain in the acute setting of a subarachnoid hemorrhage.
Flow diverters are new implantable medical devices that make possible to embolize wide-necked aneurysms without the use of coils; the efficacy results published to date are encouraging in terms of complete occlusion in the medium-term, thereby confirming the innovative nature of the flow diversion technique that we aim to evaluate without the use of coils.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Aneurysm
Keywords
wide necked intracranial 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
Intervention Type
Procedure
Intervention Name(s)
aneurysm clipping
Other Intervention Name(s)
aneurysm coiling, flow diversion
Intervention Description
treatment of wide necked intracranial aneurysms using different modalities as open surgery by clipping or endovascular techniques as coiling and flow diversion
Primary Outcome Measure Information:
Title
Independent clinical outcome changes
Description
The changes in clinical condition of the patients will be assessed before and after treatment using modified Rankin scale, as the scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
Time Frame
one day before treatment, within 3 days after treatment.
Title
Postoperative angiographic occlusion rate changes
Description
The changes in postoperative angiographic occlusion rate will be assessed in different time frame using CT angiography or conventional angiography (if CT angiography is not conclusive)
Time Frame
within 3 days after treatment and after 6 months
Secondary Outcome Measure Information:
Title
incidence of aneurysm rupture
Description
as complication of treatment
Time Frame
during operation or within 7 days after treatment
Title
incidence of cerebral vasospasm
Description
as complication of treatment
Time Frame
within 30 days after treatment
Title
Mortality rate
Description
as a result of treatment
Time Frame
within 30 days after treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Patients who undergo surgical clipping or any endovascular techniques used in treatment of wide-necked intracranial aneurysms. Wide-necked aneurysms are defined as aneurysms with a fundus-to-neck ratio of less than 2 or a neck diameter of 14 mm.
Exclusion Criteria:
patients with narrow-necked intracranial aneurysms
patients who are unfit for any neurosurgical interventions.
patients who had artery aneurysm and vascular malformation due to some trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Ahmed Abokresha, Assisstant professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed El-Sayed Mahmoud, Assisstant professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abd El-hai Moussa Abd El-Latif, professor of neurosurgery
Organizational Affiliation
Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of medicine
City
Assuit
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24646873
Citation
Brown RD Jr, Broderick JP. Unruptured intracranial aneurysms: epidemiology, natural history, management options, and familial screening. Lancet Neurol. 2014 Apr;13(4):393-404. doi: 10.1016/S1474-4422(14)70015-8.
Results Reference
background
PubMed Identifier
17332442
Citation
Wermer MJ, van der Schaaf IC, Algra A, Rinkel GJ. Risk of rupture of unruptured intracranial aneurysms in relation to patient and aneurysm characteristics: an updated meta-analysis. Stroke. 2007 Apr;38(4):1404-10. doi: 10.1161/01.STR.0000260955.51401.cd. Epub 2007 Mar 1.
Results Reference
background
PubMed Identifier
12063434
Citation
Matillon Y. [Ruptured intracranial aneurysms: Occlusion by endovascular approach versus exclusion by microsurgery]. J Radiol. 2002 May;83(5):662-4. No abstract available. French.
Results Reference
background
PubMed Identifier
17569982
Citation
Layton KF, Cloft HJ, Gray LA, Lewis DA, Kallmes DF. Balloon-assisted coiling of intracranial aneurysms: evaluation of local thrombus formation and symptomatic thromboembolic complications. AJNR Am J Neuroradiol. 2007 Jun-Jul;28(6):1172-5. doi: 10.3174/ajnr.A0490.
Results Reference
background
PubMed Identifier
20678369
Citation
Moret J, Cognard C, Weill A, Castaings L, Rey A. The "Remodelling Technique" in the Treatment of Wide Neck Intracranial Aneurysms. Angiographic Results and Clinical Follow-up in 56 Cases. Interv Neuroradiol. 1997 Mar 30;3(1):21-35. doi: 10.1177/159101999700300103. Epub 2001 May 15.
Results Reference
background
PubMed Identifier
9672035
Citation
Baxter BW, Rosso D, Lownie SP. Double microcatheter technique for detachable coil treatment of large, wide-necked intracranial aneurysms. AJNR Am J Neuroradiol. 1998 Jun-Jul;19(6):1176-8.
Results Reference
background
PubMed Identifier
16944050
Citation
Ihn YK, Kim DI, Kim BS, Lee JM. Utility of catheter-assisted Guglielmi detachable coiling in the treatment of wide-necked aneurysms. Acta Neurochir (Wien). 2006 Oct;148(10):1045-52; discussion 1052. doi: 10.1007/s00701-006-0881-7. Epub 2006 Sep 8.
Results Reference
background
PubMed Identifier
24641489
Citation
Gory B, Sigovan M, Vallecilla C, Courbebaisse G, Turjman F. High-resolution MRI visualization of aneurysmal thrombosis after flow diverter stent placement. J Neuroimaging. 2015 Mar-Apr;25(2):310-311. doi: 10.1111/jon.12110. Epub 2014 Mar 19.
Results Reference
background
PubMed Identifier
23321438
Citation
Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013 Feb;44(2):442-7. doi: 10.1161/STROKEAHA.112.678151. Epub 2013 Jan 15.
Results Reference
background
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Current Treatment Modalities for Wide Necked Intracranial Aneurysms
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