Cerebrovascular DiseaseHOTAVMNCT03774017
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations
A study testing one-staged hybrid operation and Traditional microsurgical operation in people with Cerebrovascular Disease and Arteriovenous Malformations, run by Ministry of Science and Technology of the People´s Republic of China at 7 sites in China.
Trial summary
Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of… Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Cerebrovascular Disease, Arteriovenous Malformations, Complex; Primary
- What is being tested?
- one-staged hybrid operation and Traditional microsurgical operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jan 2016to 31 Dec 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients of all ages;
- diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
- with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;
- with Spetzler-Martin Grades from I to IV;
- who provide informed consent.
Who cannot join
- >70 years old with no significant hemorrhagic risk of bAVMs;
- with Spetzler-Martin Grade ≥V;
- accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
- allergic to iodinated contrast agent;
- unable to give informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Guilin Li, MD, 861083198899
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100070
Shuo Wang, MD, 861059976510, captain9858@vip.sina.com
Jun Wu, MD, 861059976510, wujunslf@126.com
- Recruiting
General Hospital of Rocket Army
Beijing, Beijing Municipality, 100088
Weijian Jiang, MD, 861066343337
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Gao Chen, MD, 8657187783777
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Donghai Wang, MD, 8653182166173
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong, 266034
Chuanfeng Li, MD, 8653282789017
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Liang Chen, MD, 860215288999, chenlianghs@126.com
About this study
Official title: Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.
Read the detailed description
The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.
- Being tested
- one-staged hybrid operation, Traditional microsurgical operation
- Keywords
- brain arteriovenous malformations, one-staged hybrid operation
- Medical subject headings
- Cerebrovascular Disorders, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-staged hybrid operationProcedure or surgery
An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.
Traditional microsurgical operationProcedure or surgery
The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation
| Study group | Role | What they receive |
|---|---|---|
| Traditional microsurgery group | Other | Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation. Receives: Procedure: Traditional microsurgical operation |
| Hybrid operation group | Experimental | Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater. Receives: Procedure: one-staged hybrid operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural function deterioration
Increasing of mRS and mRS>2
Measured: 3 months after operation
Secondary outcomes (8)
neural function deterioration in 6 months
Increasing of mRS and mRS>2
Measured: 6 months after operation
neural function deterioration in 12 months
Increasing of mRS and mRS>2
Measured: 12 months after operation
postoperative mortality
the fatality due to operation
Measured: 7 days after operation
operation-related complications
any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications
Measured: 7 days after operation
postoperative bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Measured: 7 days after operation
3 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Measured: 3 months after operation
6 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Measured: 6 months after operation
12 months bAVMs residue
the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jan 2016
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shuo Wang, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Shuo Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774017
- Sponsor's protocol ID
- BJTTH-007
- Other IDs
- 2016YFC1301801
- Acronym
- HOTAVM
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang M, Qiu H, Cao Y, Wang S, Zhao J. One-staged in situ embolization combined with surgical resection for eloquence protection of AVM: technical note. Neurosurg Rev. 2019 Sep;42(3):783-790. doi: 10.1007/s10143-019-01137-w. Epub 2019 Jul 30.
PubMed 31359304Wang M, Jiao Y, Cao Y, Wang S, Zhao J. Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial. BMC Neurol. 2019 Apr 30;19(1):75. doi: 10.1186/s12883-019-1289-3.
PubMed 31039755
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT03774017
- Acronym / sponsor ID
- HOTAVM / BJTTH-007
- Keywords
- brain arteriovenous malformations, one-staged hybrid operation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Dec 2018 (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.
Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.
Detailed description
The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional microsurgery group | Other | Procedure: Traditional microsurgical operationPatients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation. |
| Hybrid operation group | Experimental | Procedure: one-staged hybrid operationPatients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients of all ages;
- diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;
- with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced deterioration of neurological functions;
- with Spetzler-Martin Grades from I to IV;
- who provide informed consent.
Key exclusion criteria (5 listed)
- >70 years old with no significant hemorrhagic risk of bAVMs;
- with Spetzler-Martin Grade ≥V;
- accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation;
- allergic to iodinated contrast agent;
- unable to give informed consent.
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 |
|---|---|---|
| one-staged hybrid operationAn integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients. | Procedure or surgery | Hybrid operation group |
| Traditional microsurgical operationThe classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation | Procedure or surgery | Traditional microsurgery group |
Primary outcome
neural function deterioration
Time frame: 3 months after operation
Increasing of mRS and mRS>2
8 secondary outcomes
neural function deterioration in 6 months
Time frame: 6 months after operation
neural function deterioration in 12 months
Time frame: 12 months after operation
postoperative mortality
Time frame: 7 days after operation
operation-related complications
Time frame: 7 days after operation
postoperative bAVMs residue
Time frame: 7 days after operation
3 months bAVMs residue
Time frame: 3 months after operation
6 months bAVMs residue
Time frame: 6 months after operation
12 months bAVMs residue
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 31359304Wang M, Qiu H, Cao Y, Wang S, Zhao J. One-staged in situ embolization combined with surgical resection for eloquence protection of AVM: technical note. Neurosurg Rev. 2019 Sep;42(3):783-790. doi: 10.1007/s10143-019-01137-w. Epub 2019 Jul 30.
- Derived from this study: PubMed 31039755Wang M, Jiao Y, Cao Y, Wang S, Zhao J. Surgical management of complex brain arteriovenous malformations with hybrid operating technique: study protocol of a prospective registry and a pragmatic clinical trial. BMC Neurol. 2019 Apr 30;19(1):75. doi: 10.1186/s12883-019-1289-3.
- Individual participant dataSharing planned: No
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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.
Shuo Wang, MD principal investigator
Beijing Tiantan Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one-staged hybrid operation and Traditional microsurgical operation in people with Cerebrovascular Disease and Arteriovenous Malformations, run by Ministry of Science and Technology of the People´s Republic of China at 7 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 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Wang, MD (861059976510, captain9858@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural function deterioration (time frame: 3 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03774017, which also lists 2 linked publications.
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 12 Dec 2018.