Clinical trial NCT03206853: Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques
Official title: Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2017-07-02
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Traditional therapy group：the aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.

Hybrid operation group: Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: operation-related mortality rate
timeFrame: From the time of operation begin to 48 hours after operation
Secondary outcomes:
measure: Morbidity rate of peri-operative intracranial hemorrhage
timeFrame: From date of admission to the 7 days after operation
measure: Morbidity rate of peri-operative intracranial ischemic events
timeFrame: From date of admission to 7 days after operation
measure: Residual rate of aneurysms
timeFrame: the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation
measure: Morbidity rate of neural functional deterioration in 48 hours after operation
timeFrame: 48 hours after operation, ±6 hours
measure: Morbidity rate of neural functional deterioration in 7 days
timeFrame: 7 days after operation, ±2 days
measure: Morbidity rate of neural functional deterioration in 3 months
timeFrame: the 3rd month after operation, ±1 week
measure: Morbidity rate of neural functional deterioration in 6 months
timeFrame: the 6th month after operation, ±1 week
measure: Morbidity rate of neural functional deterioration in 12 months
timeFrame: the 12th month after operation, ±1 week
measure: Treatment-related costs
timeFrame: through study completion, an average of 1 year
measure: Duration of hospitalization
timeFrame: through study completion, an average of 1 year
measure: Duration of total operating time
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jizong Zhao, MD
role: STUDY_DIRECTOR
References: