Brain Aneurysm Clinical Trial
Official title:
Current Treatment Modalities for Wide Necked Intracranial Aneurysms
Verified date | May 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | March 30, 2021 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine | Assuit |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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. — View 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. Review. — View 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. Review. — View 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. — View 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. Epub 2006 Sep 8. — View 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. — View Citation
Matillon Y. [Ruptured intracranial aneurysms: Occlusion by endovascular approach versus exclusion by microsurgery]. J Radiol. 2002 May;83(5):662-4. French. — View 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. Epub 2001 May 15. — View 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. Epub 2007 Mar 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
one day before treatment, within 3 days after treatment. | |
Primary | 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 | |
Secondary | incidence of aneurysm rupture | as complication of treatment | during operation or within 7 days after treatment | |
Secondary | incidence of cerebral vasospasm | as complication of treatment | within 30 days after treatment | |
Secondary | Mortality rate | as a result of treatment | within 30 days after treatment |
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