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

• Conditions: Treatment Outcome by Stent-assisted Embolization
• Interventions: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent

• Registration Number: NCT03387995
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-11-27
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-21
• Last Update Submitted: 2017-12-21
• Study First Posted: 2018-01-02
• Last Update Posted: 2018-01-02
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Middle cerebral artery aneurysm	Solitaire stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Middle cerebral artery aneurysm	Enterprise stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Middle cerebral artery aneurysm	Neuroform stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Anterior communicating artery aneurysm	LVIS stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Anterior communicating artery aneurysm	Solitaire stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Anterior communicating artery aneurysm	Enterprise stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Anterior communicating artery aneurysm	Neuroform stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Anterior communicating artery aneurysm	Flow diverter (FD) stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Middle cerebral artery aneurysm	LVIS stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Middle cerebral artery aneurysm	Flow diverter (FD) stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Posterior communicating artery aneurysm	LVIS stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Posterior communicating artery aneurysm	Solitaire stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Posterior communicating artery aneurysm	Enterprise stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Posterior communicating artery aneurysm	Neuroform stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Posterior communicating artery aneurysm	Flow diverter (FD) stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Internal carotid artery aneurysm	LVIS stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Internal carotid artery aneurysm	Solitaire stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Internal carotid artery aneurysm	Enterprise stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Internal carotid artery aneurysm	Neuroform stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Internal carotid artery aneurysm	Flow diverter (FD) stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Vertebrobasilar system aneurysms	LVIS stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Vertebrobasilar system aneurysms	Solitaire stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Vertebrobasilar system aneurysms	Enterprise stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Vertebrobasilar system aneurysms	Neuroform stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
Vertebrobasilar system aneurysms	Flow diverter (FD) stent	Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

ZhuJiang Hospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China