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Clinical Trials/NCT03387995
NCT03387995
Unknown
Not Applicable

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

Zhujiang Hospital1 site in 1 country2,000 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Treatment Outcome by Stent-assisted Embolization
Sponsor
Zhujiang Hospital
Enrollment
2000
Locations
1
Primary Endpoint
Evaluate the relationship between intracranial aneurysm and cyclin dependent
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
September 1, 2021
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluate the relationship between intracranial aneurysm and cyclin dependent

Time Frame: 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 safety evaluation of interventional therapy

Time Frame: 6 months later after operation

Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy

The efficacy evaluation of interventional treatment

Time Frame: 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

The cerebrovascular complication after interventional therapy

Time Frame: 6 months later after operation

Perioperative and delayed cerebrovascular complication after stent deployment

The incidence of in-stent stenosis after stent deployment

Time Frame: 6 months later after operation

the rate and degree of in-stent stenosis after stent deployment

Study Sites (1)

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