Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

Intracranial Aneurysm Clinical Trial

— CIA-HOTs  

Official title:

Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03206853
• Other study ID #: BJTTH-004
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 29, 2017
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: Xingju Liu, MD
• Phone: 86-15011476305
• Email: liuxingju006[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
liuxingju	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

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