Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

Not Applicable

• Conditions: Atheroscleroses, Cerebral; Intracranial Aneurysm; Cerebrovascular Stenosis
• Interventions: Procedure: Microsurgical aneurysmal operating techniques; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: endovascular techniques for intracranial aneurysms; Procedure: carotid endarterectomy

• Registration Number: NCT03204435
• Lead Sponsor: liuxingju

Brief Summary

To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.

Detailed Description

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.

Study Timeline

• Study Start: 2016-06
• Status Verified: 2017-06
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• For aneurysms:
• 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

• >70 in age, with low rupture risk;
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional therapy	endovascular techniques for cerebrovascular stenosis	Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Traditional therapy	endovascular techniques for intracranial aneurysms	Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Traditional therapy	carotid endarterectomy	Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Hybrid operation	endovascular techniques for intracranial aneurysms	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.
Traditional therapy	Microsurgical aneurysmal operating techniques	Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.
Hybrid operation	Microsurgical aneurysmal operating techniques	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.
Hybrid operation	endovascular techniques for cerebrovascular stenosis	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.
Hybrid operation	carotid endarterectomy	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.

Primary Outcome Measures

Name	Time	Method
morbidity rate of peri-operative cerebral hemorrhagic events	through study completion, an average of 1 year	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
morbidity rate of peri-operative cerebral ischemic events	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Peri-operative mortality rate	through study completion, an average of 1 year	The mortality rate during the period of treatment
Treatment-related costs	through study completion, an average of 1 year	The total in-patient expenses of the aiming diseases, covering all treating stages
Duration of hospitalization	through study completion, an average of 1 year	The total hospitalizations for the treatment of aiming diseases, covering all treating stages
Duration of total operating time	through study completion, an average of 1 year	The total operating time, the sum of durations of multi-stages operation if several procedures are presented

Trial Locations

Locations (1)

Beijing Tiantan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China