Intracranial Arteriovenous MalformationsSMAVMHRNCT03209804
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
A study testing hybrid operating techniques in people with Intracranial Arteriovenous Malformations, run by Ministry of Science and Technology of the People´s Republic of China at 4 sites in China.
Trial summary
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intracranial Arteriovenous Malformations
- What is being tested?
- hybrid operating techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 519 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2016to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- >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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 0086
General Hospital of PLA
Beijing, Beijing Municipality, 100039
Rocket Army General Hospital of PLA
Beijing, Beijing Municipality, 100088
Beijing Hospital
Beijing, Beijing Municipality, 100730
About this study
To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.
Read the 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
- Being tested
- hybrid operating techniques
- Keywords
- Intracranial Arteriovenous Malformations
- Medical subject headings
- Intracranial Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid operating techniquesProcedure or surgery
Also called endovascular interventional embolisation, endovascular interventional balloon occlusion, microsurgical resection
A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Traditional neurosurgical techniques | Other | Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines. Receives: Procedure: hybrid operating techniques |
| Hybrid operating techniques | Experimental | A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously Receives: Procedure: hybrid operating techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instant residual rate of AVMs
The instant post-operative residual rate of AVMs
Measured: up to 1 week after operation
3 months' residual rate of AVMs
3 months' residual rate after AVM operation
Measured: the date of 3rd month after operation, ±1 week
6 months' residual rate of AVMs
6 months' residual rate after AVM operation
Measured: 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
Measured: the date of the 12th month after operation, ±1 week
Secondary outcomes (7)
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
Measured: 7 days after operation
Post-operative mortality rate
operation related mortality
Measured: 48 hours after operation
Morbidity rate of neural functional deterioration-48 hours after operation
The score of modified Rankin Scale increases ≥2
Measured: 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
Measured: 1 week after operation
Morbidity rate of neural functional deterioration-3 months after operation
The score of modified Rankin Scale increases ≥2
Measured: 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
Measured: 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
Measured: the 12th month after operation, ±1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study startJun 2016
- Primary completionDec 2019
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Arteriovenous MalformationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group. Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Shuo Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209804
- Sponsor's protocol ID
- BJTTH-002
- Acronym
- SMAVMHR
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room
- ClinicalTrials.gov ID
- NCT03209804
- Acronym / sponsor ID
- SMAVMHR / BJTTH-002
- Conditions
- Intracranial Arteriovenous Malformations
- Keywords
- Intracranial Arteriovenous Malformations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group. Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.
| Arm | Type | Receives |
|---|---|---|
| Traditional neurosurgical techniques | Other | Procedure: hybrid operating techniquesUnsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines. |
| Hybrid operating techniques | Experimental | Procedure: hybrid operating techniquesA one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- >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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hybrid operating techniquesAlso: endovascular interventional embolisation, endovascular interventional balloon occlusion, microsurgical resectionA one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion. | Procedure or surgery | Hybrid operating techniques, Traditional neurosurgical techniques |
Primary outcome
Instant residual rate of AVMs
Time frame: up to 1 week after operation
The instant post-operative residual rate of AVMs
3 months' residual rate of AVMs
Time frame: the date of 3rd month after operation, ±1 week
3 months' residual rate after AVM operation
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
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
7 secondary outcomes
Morbidity rate of post-operative complications
Time frame: 7 days after operation
Post-operative mortality rate
Time frame: 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
Morbidity rate of neural functional deterioration-1 week after operation
Time frame: 1 week after operation
Morbidity rate of neural functional deterioration-3 months after operation
Time frame: 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
Morbidity rate of neural functional deterioration-12 months after operation
Time frame: the 12th month after operation, ±1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hybrid operating techniques in people with Intracranial Arteriovenous Malformations, run by Ministry of Science and Technology of the People´s Republic of China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instant residual rate of AVMs (time frame: up to 1 week after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.