Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis
NCT ID: NCT03204435
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
196 participants
INTERVENTIONAL
2016-06-30
2019-12-31
Brief Summary
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Detailed Description
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Objects: Patients with IAs with coexistence of AIAS, coincident with inclusion and exclusion criterion and admitted in participating organizations.
Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional multi-stage neurosurgical management or one-stage hybrid operating management correspondingly. The morbidity rate of peri-operative cerebral hemorrhagic/ischemic event is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, while peri-operative mortality rate, and health-economic indicators are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Traditional therapy group: intervene the aneurysms and vascular stenosis unsimultaneously. Clipping procedure is preferred to aneurysms, while endovascular intervention is preferred to stenosis.
Hybrid operation group: one-stage hybrid operating technique is conducted. The aneurysms and vascular stenosis will be executed via the cooperation of microsurgical procedure and endovascular interventional techniques.
TREATMENT
SINGLE
Study Groups
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Traditional therapy
Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Microsurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
endovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
Hybrid operation
Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented in one-stage in hybrid operating theater.
Microsurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
endovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
Interventions
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Microsurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
endovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
endovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
carotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
* got SAH in history;
* neural functional deficits due to aneurysms;
* with \<4 in Hunt-Hess Grades;
* ≥5.0mm in the maximum diameter;
* \<70 years old;
* with irregular morphological features and high rupture risk.
and for stenosis
* Intracranial vessels:
* \>50% in rate of stenosis with ischemic symptoms/perfusing evidence/lacunar infarction in supplying territory, failed in conservative treatment;
* with a deliverable position of intracranial stents devices.
* or Vertebral arterial system:
* ≥70% in the rate of stenosis, with contralateral vertebral arterial occlusion;
* symptomatic vertebral arterial stenosis, accompanied with posterior inferior cerebellum artery derived from the affected artery and related symptoms are caused/clinical benefits can be achieved through angioplasty.
* or Extracranial arterial system:
* ≥70% in the rate of stenosis with symptoms;
* nonsymptomatic patients, ≥70% in the rate of stenosis , with perfusing evidence.
Exclusion Criteria
* stroke history in 6 weeks (contraindication for endovascular intervention);
* coexistence with intracranial tumor or AVM;
* cannot tolerant the operation;
* patient or relative refuses to participate the trail
18 Years
70 Years
ALL
No
Sponsors
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Beijing Municipal Science & Technology Commission
OTHER
liuxingju
OTHER_GOV
Responsible Party
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liuxingju
Researcher
Principal Investigators
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Jizong Zhao, MD
Role: STUDY_DIRECTOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BJTTH-005
Identifier Type: -
Identifier Source: org_study_id
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