Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

Not Applicable

• Conditions: Intracranial Aneurysm
• Interventions: Procedure: Hybrid Operating Techniques

• Registration Number: NCT03206853
• Lead Sponsor: liuxingju

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.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2017-06
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• 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: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional therapy group	Hybrid Operating Techniques	The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.
Hybrid operation group	Hybrid Operating Techniques	Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.

Primary Outcome Measures

Name	Time	Method
operation-related mortality rate	From the time of operation begin to 48 hours after operation	the mortality rate related to the operation

Secondary Outcome Measures

Name	Time	Method
Morbidity rate of peri-operative intracranial ischemic events	From date of admission to 7 days after operation	The intracranial ischemic events happening during the peri-operative period, including operation-related infarction, embolization, etc. With neuro-imaging evidence.
Residual rate of aneurysms	the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation	the morbidity rate of aneurysmal residue, with post-operative DSA/CTA evidence
Morbidity rate of neural functional deterioration in 48 hours after operation	48 hours after operation, ±6 hours	The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Duration of total operating time	through study completion, an average of 1 year	Total operating time of all procedures, including operation, and DSA
Morbidity rate of peri-operative intracranial hemorrhage	From date of admission to the 7 days after operation	Intracranial hemorrhagic events happening during the peri-operative period, including subarachnoid hemorrhage, intracranial hemorrhage, intraventricular hemorrhage caused by the rupture of aneurysms with neuro-imaging evidence.
Morbidity rate of neural functional deterioration in 12 months	the 12th month after operation, ±1 week	The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Treatment-related costs	through study completion, an average of 1 year	All expenses cost in hospital relating to the aiming disease
Duration of hospitalization	through study completion, an average of 1 year	Total hospitalization of all stages of treatments to IAs, including admissions for evaluation, operation, and DSA
Morbidity rate of neural functional deterioration in 7 days	7 days after operation, ±2 days	The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Morbidity rate of neural functional deterioration in 3 months	the 3rd month after operation, ±1 week	The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores
Morbidity rate of neural functional deterioration in 6 months	the 6th month after operation, ±1 week	The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores

Trial Locations

Locations (1)

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