NCT03209804

Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 519 (actual)
• Sponsor: Ministry of Science and Technology of the People´s Republic of China · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Intracranial Arteriovenous Malformations

Interventions

Type	Name	Description
PROCEDURE	hybrid operating techniques	A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-12-01
• Completion: 2020-01-16
• First posted: 2017-07-06
• Last updated: 2020-03-13

Locations

4 sites across 1 country: China