Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

Intracranial Arteriovenous Malformations Clinical Trial

— SMAVMHR  

Official title:

Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209804
• Other study ID #: BJTTH-002
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 16, 2020

Study information

• Verified date: March 2020
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Description:

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, 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. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration 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: Completed
• Enrollment: 519
• Est. completion date: January 16, 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• newly ruptured AVM with stable hematoma, selective operation is practical;

• with rupture history;

• recurrent epilepsy, failed in AED management;

• giant AVM with deterioration of neurological functions;

• 1-4 grade AVM (Spetzler-Martin grading system) with no symptom and not located in eloquent area.

Exclusion Criteria:

• >70 in age, with low rupture risk;

• newly ruptured AVM with unstable hematoma, engaged in emergency operation;

• =5 grade in Spetzler-Martin grading system;

• AVM located in hypothalamus, brainstem, cerebellopontine angle;

• cannot tolerant the operation;

• patient or relative refuses to participate the trail.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Intervention

Procedure:
• hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing
China	General Hospital of PLA	Beijing	Beijing
China	Rocket Army General Hospital of PLA	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instant residual rate of AVMs	The instant post-operative residual rate of AVMs	up to 1 week after operation
Primary	3 months' residual rate of AVMs	3 months' residual rate after AVM operation	the date of 3rd month after operation, ±1 week
Primary	6 months' residual rate of AVMs	6 months' residual rate after AVM operation	the date of the 6th month after operation, ±1 week
Primary	1 year's residual rate of AVMs	1 year's residual rate after AVM operation	the date of the 12th month after operation, ±1 week
Secondary	Morbidity rate of post-operative complications	Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications	7 days after operation
Secondary	Post-operative mortality rate	operation related mortality	48 hours after operation
Secondary	Morbidity rate of neural functional deterioration-48 hours after operation	The score of modified Rankin Scale increases =2	the assessing time points is 48 hours after operation
Secondary	Morbidity rate of neural functional deterioration-1 week after operation	The score of modified Rankin Scale increases =2	1 week after operation
Secondary	Morbidity rate of neural functional deterioration-3 months after operation	The score of modified Rankin Scale increases =2	the 3rd month after operation, ±1 week
Secondary	Morbidity rate of neural functional deterioration-6 months after operation	The score of modified Rankin Scale increases =2	the 6th month after operation, ±1 week
Secondary	Morbidity rate of neural functional deterioration-12 months after operation	The score of modified Rankin Scale increases =2	the 12th month after operation, ±1 week