Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)

Zhujiang Hospital

Status: Completed

Conditions: Treatment Outcome by Stent-assisted Embolization

Treatments: Device: Solitaire stent; Device: Neuroform stent; Device: Flow diverter (FD) stent; Device: LVIS stent; Device: Enterprise stent

Study type: Observational

Funder types: Other

Identifiers

NCT03387995

LC2016ZD024

Details and patient eligibility

About

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.

Full description

Studies showed 3.6% - 6% for the incidence and 1% - 2% for the ruptctued rate of IA.The mortality and morbidity account for 22% to 25% in cerebrovascular disease ,which is a growing trend. IA is one of the major diseases which relate with people's living standards. Endovascular embolization is one of the main treatments of IA with less invasive, Better cure rates and higher safety. It has been developed rapidly and improve quality of patients' lives after treatmen.With the rapid development of neural intervention and the proliferation of specialized stents in IA, stent-assisted embolization technique is becoming more and more common .Especially, stents play an important role in intracranial aneurysmal aneurysm.

There are many kinds intracranial stents for clinical surgery, but how to choose the appropriate stent type is one of the key issues that clinicians need to settle. And, there is no relevant multicenter cases study about selection strategy of intracranial stent at home and abroad.

Enrollment: 4,157 patients

Sex: All

Ages: 14 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm)
• Subject has received previous surgical clipping or endovascular treatment
• 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
• History of aneurysm

Trial design

4,157 participants in 5 patient groups

Anterior communicating artery aneurysm

Description:

Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Treatment:

Device: Enterprise stent

Device: LVIS stent

Device: Flow diverter (FD) stent

Device: Neuroform stent

Device: Solitaire stent

Middle cerebral artery aneurysm

Description:

Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Treatment:

Device: Enterprise stent

Device: LVIS stent

Device: Flow diverter (FD) stent

Device: Neuroform stent

Device: Solitaire stent

Posterior communicating artery aneurysm

Description:

Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Treatment:

Device: Enterprise stent

Device: LVIS stent

Device: Flow diverter (FD) stent

Device: Neuroform stent

Device: Solitaire stent

Internal carotid artery aneurysm

Description:

Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Treatment:

Device: Enterprise stent

Device: LVIS stent

Device: Flow diverter (FD) stent

Device: Neuroform stent

Device: Solitaire stent

Vertebrobasilar system aneurysms

Description:

Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Treatment:

Device: Enterprise stent

Device: LVIS stent

Device: Flow diverter (FD) stent

Device: Neuroform stent

Device: Solitaire stent