Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

NCT ID: NCT03206853

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hybrid operation group

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

Group Type: EXPERIMENTAL

Hybrid Operating Techniques

Intervention Type: PROCEDURE

It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.

Traditional therapy group

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

Group Type: OTHER

Hybrid Operating Techniques

Intervention Type: PROCEDURE

It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.

Interventions

Hybrid Operating Techniques

It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.

Intervention Type: PROCEDURE

Other Intervention Names

microsurgical clipping; microsurgical dissection; microsurgical wrapping; microsurgical isolation; endovascular coiling; balloon-assisted occlusion; flow diverter

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

liuxingju

OTHER_GOV

Sponsor Role: lead

Responsible Party

liuxingju

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jizong Zhao, MD

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingju Liu, MD

Role: CONTACT

liuxingju006@163.com

86-15011476305

Mingze Wang, MD

Role: CONTACT

wmz_01@sina.com

86-13699290543

Facility Contacts

liu xingju, MD

Role: primary

liuxingju006@163.com

008615011476305

Other Identifiers

BJTTH-004

Identifier Type: -

Identifier Source: org_study_id