- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03209804
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room (SMAVMHR)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Beijing Hospital
-
Beijing, Beijing, China, 0086
- Beijing Tiantan Hospital Capital Medical University
-
Beijing, Beijing, China, 100039
- General Hospital of PLA
-
Beijing, Beijing, China, 100088
- Rocket Army General Hospital of PLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Traditional neurosurgical techniques
Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.
|
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
|
Experimental: Hybrid operating techniques
A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously
|
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instant residual rate of AVMs
Time Frame: up to 1 week after operation
|
The instant post-operative residual rate of AVMs
|
up to 1 week after operation
|
3 months' residual rate of AVMs
Time Frame: the date of 3rd month after operation, ±1 week
|
3 months' residual rate after AVM operation
|
the date of 3rd month after operation, ±1 week
|
6 months' residual rate of AVMs
Time Frame: the date of the 6th month after operation, ±1 week
|
6 months' residual rate after AVM operation
|
the date of the 6th month after operation, ±1 week
|
1 year's residual rate of AVMs
Time Frame: the date of the 12th month after operation, ±1 week
|
1 year's residual rate after AVM operation
|
the date of the 12th month after operation, ±1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morbidity rate of post-operative complications
Time Frame: 7 days after operation
|
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
|
Post-operative mortality rate
Time Frame: 48 hours after operation
|
operation related mortality
|
48 hours after operation
|
Morbidity rate of neural functional deterioration-48 hours after operation
Time Frame: the assessing time points is 48 hours after operation
|
The score of modified Rankin Scale increases ≥2
|
the assessing time points is 48 hours after operation
|
Morbidity rate of neural functional deterioration-1 week after operation
Time Frame: 1 week after operation
|
The score of modified Rankin Scale increases ≥2
|
1 week after operation
|
Morbidity rate of neural functional deterioration-3 months after operation
Time Frame: the 3rd month after operation, ±1 week
|
The score of modified Rankin Scale increases ≥2
|
the 3rd month after operation, ±1 week
|
Morbidity rate of neural functional deterioration-6 months after operation
Time Frame: the 6th month after operation, ±1 week
|
The score of modified Rankin Scale increases ≥2
|
the 6th month after operation, ±1 week
|
Morbidity rate of neural functional deterioration-12 months after operation
Time Frame: the 12th month after operation, ±1 week
|
The score of modified Rankin Scale increases ≥2
|
the 12th month after operation, ±1 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Cardiovascular Abnormalities
- Neoplasms, Vascular Tissue
- Nervous System Malformations
- Vascular Malformations
- Intracranial Arterial Diseases
- Central Nervous System Vascular Malformations
- Congenital Abnormalities
- Hemangioma
- Arteriovenous Malformations
- Intracranial Arteriovenous Malformations
Other Study ID Numbers
- BJTTH-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intracranial Arteriovenous Malformations
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingAVM (Arteriovenous Malformation) IntracranialItaly
-
Centre hospitalier de l'Université de Montréal...Active, not recruitingUnruptured Brain Arteriovenous Malformation | Ruptured Brain Arteriovenous Malformation | Arteriovenous Malformations, CerebralCanada, France
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
-
Medtronic Neurovascular Clinical AffairsCompletedCerebral Arteriovenous MalformationsFrance
-
Microvention-Terumo, Inc.ClinSearchTerminatedCerebral AV MalformationUnited Kingdom, Spain, Denmark, France, Sweden
-
Seoul National University HospitalRecruitingBrain Neoplasms | Cerebral Aneurysm | Cerebral Arteriovenous Malformation | Navigation, SpatialKorea, Republic of
-
NYU Langone HealthCompletedIntracranial Arteriovenous Malformations (AVM)
-
University Hospital, BonnUnknownSubarachnoid Hemorrhage | Intracranial Arteriovenous MalformationGermany
-
Erasme University HospitalCompletedArteriovenous Fistula | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, Intracranial | Stenosis | Ruptured Cerebral Aneurysm | Arteriovenous Malformations, CerebralBelgium
-
Embo-Flüssigkeiten A.G.Active, not recruitingCerebral Arteriovenous MalformationFrance, Denmark, Germany, Belgium, Italy
Clinical Trials on hybrid operating techniques
-
liuxingjuBeijing Municipal Science & Technology CommissionUnknownIntracranial AneurysmChina
-
Mansoura UniversityCompletedProsthesis DurabilityEgypt
-
liuxingjuBeijing Municipal Science & Technology CommissionUnknownIntracranial Aneurysm | Atheroscleroses, Cerebral | Cerebrovascular StenosisChina
-
Maternal and Child Health Hospital of FoshanRecruitingEmergency Cesarean SectionChina
-
Imperial College LondonTerminated
-
Beijing Tsinghua Chang Gung HospitalEnrolling by invitation
-
Sandwell & West Birmingham Hospitals NHS TrustCompletedFractures, Bone | Orthopedic Disorder | Neck of Femur FractureUnited Kingdom
-
Data Collection Analysis Business ManagementPAS Research ServicesUnknownDietary Allergy | Environmental AllergyUnited States
-
National Institute of Diabetes and Digestive and...RecruitingHealthy | Obesity | Diabetes | Atherosclerosis | Healthy VolunteersUnited States
-
Antalya Training and Research HospitalCompleted