Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques (CIA-HOTs)

liuxingju

Status: Unknown

Conditions: Intracranial Aneurysm

Treatments: Procedure: Hybrid Operating Techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT03206853

BJTTH-004

Details and patient eligibility

About

To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.

Full description

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms (CIAs), which could coexists with multiple risk factors. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with CIAs, 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 neurosurgical management or one-stage hybrid operating management correspondingly. Peri-operative mortality rate is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, morbidity rate of aneurysmal residuals, morbidity rate of neural functional deteriorations, 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: 258 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• >70 in age, with low rupture risk;
• cannot tolerant the operation;
• patient or relative refuses to participate the trail;
• SAH patient with ≥4 Hunt-Hess grading system;
• <5.0mm in the maximum diameter.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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258 participants in 2 patient groups

Hybrid operation group

Experimental group

Description:

Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.

Treatment:

Procedure: Hybrid Operating Techniques

Traditional therapy group

Other group

Description:

The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.

Treatment:

Procedure: Hybrid Operating Techniques