An interventional study of hybrid operating techniques in Intracranial Arteriovenous Malformations, sponsored by Ministry of Science and Technology of the People´s Republic of China. Completed at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by Ministry of Science and Technology of the People´s Republic of China · Not applicable, Interventional, and Treatment
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
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.
141 studies on the registry are indexed under Hemangioma; 16 are open to participants now.
This study's enrollment of 519 is above the median of 50 across 80 interventional studies indexed under Hemangioma.
Browse Hemangioma studies →Ministry of Science and Technology of the People´s Republic of China is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
Procedure: hybrid operating techniques
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
Procedure: hybrid operating techniques
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Also known as: endovascular interventional embolisation, endovascular interventional balloon occlusion, microsurgical resection
Instant residual rate of AVMs
The instant post-operative residual rate of AVMs
Time frame: up to 1 week after operation
3 months' residual rate of AVMs
3 months' residual rate after AVM operation
Time frame: the date of 3rd month after operation, ±1 week
6 months' residual rate of AVMs
6 months' residual rate after AVM operation
Time frame: the date of the 6th month after operation, ±1 week
1 year's residual rate of AVMs
1 year's residual rate after AVM operation
Time frame: the date of the 12th month after operation, ±1 week
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
Time frame: 7 days after operation
Post-operative mortality rate
operation related mortality
Time frame: 48 hours after operation
Morbidity rate of neural functional deterioration-48 hours after operation
The score of modified Rankin Scale increases ≥2
Time frame: the assessing time points is 48 hours after operation
Morbidity rate of neural functional deterioration-1 week after operation
The score of modified Rankin Scale increases ≥2
Time frame: 1 week after operation
Morbidity rate of neural functional deterioration-3 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 3rd month after operation, ±1 week
Morbidity rate of neural functional deterioration-6 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 6th month after operation, ±1 week
Morbidity rate of neural functional deterioration-12 months after operation
The score of modified Rankin Scale increases ≥2
Time frame: the 12th month after operation, ±1 week
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Ministry of Science and Technology of the People´s Republic of China