Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)
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Trial details
- Who runs it
- Zhujiang Hospital
- Trial code
- NCT03387995
- Record updated
- 23 September 2024
- Original description
Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene（CDKN2BAS1 gene）of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.Read full original descriptionShow less
Safety and Efficacy of Stent Deployment for Intracranial Aneurysms: Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics
Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene（CDKN2BAS1 gene）of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.
Inclusion: Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography(DSA); Subject has accepted stent - assisted embolization or flow-diversion treatment of intracranial aneurysm.
Exclusion: Subject has received previous surgical clipping or endovascular treatment; Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm); History of aneurysm; Subject has no intracranial aneurysms by DSA; Subject with poor image quality; Subject cannot use stent because of the small parent artery; Subject do not need to use stent because of narrow-neck aneurysm.