Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis (HOT-CIACS)

liuxingju

Status: Unknown

Conditions: Cerebrovascular Stenosis; Atheroscleroses, Cerebral; Intracranial Aneurysm

Treatments: Procedure: carotid endarterectomy; Procedure: endovascular techniques for intracranial aneurysms; Procedure: endovascular techniques for cerebrovascular stenosis; Procedure: Microsurgical aneurysmal operating techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT03204435

BJTTH-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Traditional therapy

Other group

Description:

Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages.

Treatment:

Procedure: carotid endarterectomy

Procedure: Microsurgical aneurysmal operating techniques

Procedure: endovascular techniques for cerebrovascular stenosis

Procedure: endovascular techniques for intracranial aneurysms

Hybrid operation

Experimental group

Description:

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.

Treatment:

Procedure: carotid endarterectomy

Procedure: Microsurgical aneurysmal operating techniques

Procedure: endovascular techniques for cerebrovascular stenosis

Procedure: endovascular techniques for intracranial aneurysms