Treatment Outcome by Stent-assisted Embolization
Conditions
Keywords
treatment outcome
Brief summary
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
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.
Interventions
DEVICELVIS stent
The paitents treated by LVIS stent implantation.
DEVICESolitaire stent
The paitents treated by Solitaire stent implantation.
DEVICEEnterprise stent
The paitents treated by Enterprise stent implantation.
DEVICENeuroform stent
The paitents treated by Neuroform stent implantation.
DEVICEFlow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Sponsors
Nanfang Hospital, Southern Medical University
Guangdong Provincial People's Hospital
Beijing Tiantan Hospital
First Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Southwest Medical University
Guangdong 999 Brain Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of in-stent stenosis after stent deployment | 6 months later after operation | the rate and degree of in-stent stenosis after stent deployment |
| The safety evaluation of interventional therapy | 6 months later after operation | Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy |
| The efficacy evaluation of interventional treatment | 6 months later after operation | Raymond-Ray scale (for common stent) and O'Kelley Morrota scale (for FD) to measure the effectiveness of interventional treatment |
| Evaluate the relationship between intracranial aneurysm and cyclin dependent | 6 months later after operation | The investigators will take the participant's blood and the relationship between intracranial aneurysm and CDKN2BAS1 will be evaluated by ligase detection reaction-polymerase chain reaction(LDP-PCR) |
| The cerebrovascular complication after interventional therapy | 6 months later after operation | Perioperative and delayed cerebrovascular complication after stent deployment |
Other
| Measure | Time frame | Description |
|---|---|---|
| The efficacy evaluation of interventional treatment | 24 months later after operation | Raymond-Ray scale (for common stent) and O'Kelley Morrota scale (for FD) to measure the effectiveness of interventional treatment |
| The cerebrovascular complication after interventional therapy | 24 months later after operation | Delayed cerebrovascular complication during follow-up |
| The incidence of in-stent stenosis after stent deployment | 24 months later after operation | the rate and degree of in-stent stenosis after stent deployment |
| The safety evaluation of interventional therapy | 24 months later after operation | Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy |
Countries
China
Outcome results
None listed