Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics of Treatment of IA Using Stents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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the Treatment of Intracranial Aneurysm Using Different Types of Stents Assisted Embolization :Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics

Conditions
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Treatment Outcome by Stent-assisted Embolization

Intervention / Treatment
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* Device: LVIS stent
* Device: Solitire stent
* Device: Enterprise stent
* Device: Neuroform stent
* Device: Pipeline stent


Participation Criteria
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Eligibility Criteria
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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 treatment of intracranial aneurysm Exclusion Criteria: Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm) Subject has received surgical clipping or endovascular treatment Subject has no intracranial aneurysms by DSA Subject has no aneurysm measurement Aneurysm of patients are not clear by imaging 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior communicating artery aneurysm<br>Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent. | Device: LVIS stent<br>* The group has 80 patients.<br>Device: Solitire stent<br>* The group has 80 patients.<br>Device: Enterprise stent<br>* The group has 80 patients.<br>Device: Neuroform stent<br>* The group has 80 patients.<br>Device: Pipeline stent<br>* The group has 80 patients.<br>|
| Middle cerebral artery aneurysm<br>Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent. | Device: LVIS stent<br>* The group has 80 patients.<br>Device: Solitire stent<br>* The group has 80 patients.<br>Device: Enterprise stent<br>* The group has 80 patients.<br>Device: Neuroform stent<br>* The group has 80 patients.<br>Device: Pipeline stent<br>* The group has 80 patients.<br>|
| Posterior communicating artery aneurysm<br>Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent. | Device: LVIS stent<br>* The group has 80 patients.<br>Device: Solitire stent<br>* The group has 80 patients.<br>Device: Enterprise stent<br>* The group has 80 patients.<br>Device: Neuroform stent<br>* The group has 80 patients.<br>Device: Pipeline stent<br>* The group has 80 patients.<br>|
| Internal carotid artery aneurysm<br>Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent. | Device: LVIS stent<br>* The group has 80 patients.<br>Device: Solitire stent<br>* The group has 80 patients.<br>Device: Enterprise stent<br>* The group has 80 patients.<br>Device: Neuroform stent<br>* The group has 80 patients.<br>Device: Pipeline stent<br>* The group has 80 patients.<br>|
| Vertebrobasilar system aneurysms<br>Contains 5 subgroups:LVIS stent,Solitire stent,Enterprise stent,Neuroform stent and Pipeline stent. | Device: LVIS stent<br>* The group has 80 patients.<br>Device: Solitire stent<br>* The group has 80 patients.<br>Device: Enterprise stent<br>* The group has 80 patients.<br>Device: Neuroform stent<br>* The group has 80 patients.<br>Device: Pipeline stent<br>* The group has 80 patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The security evaluation of interventional therapy | Modified Rankin score to measure the security of of interventional therapy | 6 months later after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment outcome