Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aneurysm clipping | Procedure | treatment of wide necked intracranial aneurysms using different modalities as open surgery by clipping or endovascular techniques as coiling and flow diversion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| one day before treatment, within 3 days after treatment. |
| 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) | within 3 days after treatment and after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of aneurysm rupture | as complication of treatment | during operation or within 7 days after treatment |
| incidence of cerebral vasospasm | as complication of treatment |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Ahmed Abokresha, Assisstant professor | Assiut University | Study Director |
| Mohamed El-Sayed Mahmoud, Assisstant professor | Assiut University | Study Director |
| Abd El-hai Moussa Abd El-Latif, professor of neurosurgery | Assiut University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24646873 | Background | 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. | |
| 17332442 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| within 30 days after treatment |
| Mortality rate | as a result of treatment | within 30 days after treatment |
| 12063434 | Background | 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. |
| 17569982 | Background | 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. |
| 20678369 | Background | 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. |
| 9672035 | Background | 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. |
| 16944050 | Background | 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. |
| 24641489 | Background | 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. |
| 23321438 | Background | 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. |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |