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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms (IAs) with coexistence of atherosclerotic intracranial arterial stenosis (AIAS), whose management strategies are inconsistent. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional therapy | Other | Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages. |
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| Hybrid operation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microsurgical aneurysmal operating techniques | Procedure | The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation. |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity rate of peri-operative cerebral hemorrhagic events | the morbidity rate of cerebral hemorrhagic events, with significant neuro-image evidence, during the period of treatment, including SAH/ICH/IVH caused by IAs, and intracranial hemorrhages caused by interventions focusing on AIAS | through study completion, an average of 1 year |
| morbidity rate of peri-operative cerebral ischemic events | the morbidity rate of cerebral ischemic events, with significant neuro-image evidence, during the period of treatment, including all cerebral infarctions caused by interventions focusing on IAs and AIAS. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative mortality rate | The mortality rate during the period of treatment | through study completion, an average of 1 year |
| Treatment-related costs | The total in-patient expenses of the aiming diseases, covering all treating stages |
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Inclusion Criteria:
and for stenosis
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingju Liu, MD | Contact | 86-010-67096523 | liuxingju006@163.com | |
| Mingze Wang, MD | Contact | 86-010-67096510 | wmz_01@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jizong Zhao, MD | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
the IPD will be open to public researchers in 6 months after the study closed
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Patients of intracranial aneurysms with coexistence of cerebrovascular stenosis, coincident with inclusion and exclusion criterion, will be distributed into traditional therapy group(control group) and hybrid operating group(test group), and conduct with traditional neurosurgical management or one-stage hybrid operating management separately.
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.
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| endovascular techniques for cerebrovascular stenosis | Procedure | The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation. |
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| endovascular techniques for intracranial aneurysms | Procedure | The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion. |
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| carotid endarterectomy | Procedure | A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery. |
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| through study completion, an average of 1 year |
| Duration of hospitalization | The total hospitalizations for the treatment of aiming diseases, covering all treating stages | through study completion, an average of 1 year |
| Duration of total operating time | The total operating time, the sum of durations of multi-stages operation if several procedures are presented | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D004691 | Endarterectomy |
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