Intracranial Arteriovenous MalformationsNTSIAVMCNCT01803685
Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China
An observational study of Intracranial Arteriovenous Malformations, run by Dr. Yong Cao at 1 site in China.
Trial summary
This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Arteriovenous Malformations
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Sep 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
Who may be able to join
- All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
- All patients gave written informed consent
Who cannot join
- patients refuse to attend the survey
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Yong Cao, MD, 8610 67096510, caoyong6@hotmail.com
Shuo Wang, MD
About this study
Official title: A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China
This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.
Read the detailed description
Intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. The treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. We have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. But we know little about the current treatment situation of the disease in China.
In order to realize the treatment situation of intracranial arteriovenous malformation in China, we designed a retrospective and prospective register study to collect the treatment and outcome information all over China.
- Conditions
- Intracranial Arteriovenous Malformations
- Keywords
- Intracranial Arteriovenous Malformations, Surgical removal, Endovascular embolism, Stereotaxic radiosurgery, Outcomes
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Surgical resection of intracranial arteriovenous malformations. | |
| Stereotaxic radiosurgery | Deliver a relatively high dose of focused radiation precisely to the arteriovenous malformations. | |
| Endovascular treatment | Deliver embolic materials to the feeding arteries or the nidus by microcatheters | |
| Comprehensive treatment | Use two or three methods ( Surgical treatment stereotaxic radiosurgery endovascular treatment ) to cure the intracranial arteriovenous malformations | |
| Conservative treatment | Patients refused to any of the treatment above |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Ranking Scale
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead
Measured: six months after operation
Secondary outcomes (1)
Treatment complications
Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury
Measured: six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dr. Yong Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Yong Cao, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, MD, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803685
- Sponsor's protocol ID
- IAVM-125R
- Acronym
- NTSIAVMC
- Status last verified
- Mar 2013
- First submitted
- 1 Mar 2013
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China
- ClinicalTrials.gov ID
- NCT01803685
- Acronym / sponsor ID
- NTSIAVMC / IAVM-125R
- Conditions
- Intracranial Arteriovenous Malformations
- Keywords
- Intracranial Arteriovenous Malformations, Surgical removal, Endovascular embolism, Stereotaxic radiosurgery, Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dr. Yong CaoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 4 Mar 2013 (estimated)
- 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.
This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.
Detailed description
Intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. The treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. We have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. But we know little about the current treatment situation of the disease in China.
In order to realize the treatment situation of intracranial arteriovenous malformation in China, we designed a retrospective and prospective register study to collect the treatment and outcome information all over China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | –Surgical resection of intracranial arteriovenous malformations. |
| Stereotaxic radiosurgery | – | –Deliver a relatively high dose of focused radiation precisely to the arteriovenous malformations. |
| Endovascular treatment | – | –Deliver embolic materials to the feeding arteries or the nidus by microcatheters |
| Comprehensive treatment | – | –Use two or three methods ( Surgical treatment stereotaxic radiosurgery endovascular treatment ) to cure the intracranial arteriovenous malformations |
| Conservative treatment | – | –Patients refused to any of the treatment above |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
Key inclusion criteria (2 listed)
- All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
- All patients gave written informed consent
Key exclusion criteria (1 listed)
- patients refuse to attend the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Ranking Scale
Time frame: six months after operation
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead
1 secondary outcome
Treatment complications
Time frame: six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
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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.
Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, China
Shuo Wang, MD study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Arteriovenous Malformations, run by Dr. Yong Cao at 1 site 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 2 inclusion and 1 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 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Ranking Scale (time frame: six months after operation). 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 4 Mar 2013.