Spinal Cord Vascular DiseasesSUIT-SAVMNCT03024749
Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas
An observational study of Spinal Cord Vascular Diseases, run by Hongqi Zhang, MD at 1 site in China.
Trial summary
Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex neurosurgical lesions that are very challenging to manage. Spinal vascular malformations account for 3%-4% of all intradural spinal cord mass lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Vascular Diseases
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 31 Dec 2019
- How long will I take part?
- 12 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: patients with spinal AVMs/AVFs
Who may be able to join
- patient diagnosed with spinal vascular diseases including
- intradural arteriovenous malformation,
- intradural arteriovenous fistula,
- dural arteriovenous fistula,
- extradural arteriovenous malformation,
- paravertebral arteriovenous malformation,
Show all 13Show fewer
- paravertebral arteriovenous fistula,
- cobbs' syndrome,
- other spinal arteriovenous metameric syndromes involve the spinal cord.
- patient not received surgical or interventional treatment before
- patient with normal cardiac, renal and hepatic function
- patient capable of understanding the content of the patient information / Informed Consent Form
- patient willing and able to participate in the registry
Who cannot join
- patient received surgical treatment or interventional treatment before
- patient is pregnant
- patient allergic to iodine
- patient unable to complete follow-up
- patient with cerebral lesions
- patient with other spinal lesions
- patient with cardiac, renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study
Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex neurosurgical lesions that are very challenging to manage. Spinal vascular malformations account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our understanding of these lesions has dramatically increased thanks to neuroimaging technology (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities including conservative observation, endovascular embolization, microsurgical resection, radiation therapy, and combined therapies have been reported. The treatment for these AVMs and AVFs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. Due to the rarity of these spinal vascular lesions, reports of their management and outcomes have been limited to small series and case reports. And the rates of obliteration and outcomes are not satisfactory, especially the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for the treating neurosurgeon.The purpose of this study is to establish multimodality treatment mode and evaluate the anatomical cure rate and functional preservation rate.
Read the detailed description
This is a multicenter, prospective, observational, registration study. There are nine centers involved in the study. The investigators set up a more detailed classification system for spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria, this cohort study will include 380 samples in the study period of three years. According to the spinal angiography, the correct diagnosis and treatment strategy will be made. The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients will be visited a total of four times, postoperative day 1 and postoperative day 7, followed up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function will be assessed objectively. All data will be recorded in the network database platform.
- Conditions
- Spinal Cord Vascular Diseases
- Keywords
- Spinal Arteriovenous Malformation, Spinal Arteriovenous Fistula
- Medical subject headings
- Spinal Cord Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the spinal cord function
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.
Measured: 1 day before operation and 12 months postoperative
Secondary outcomes (5)
Anatomic obliteration rate
the anatomic obliteration rate is determined by angiography 3 months post operation.
Measured: 3 months post operation
American Spinal Injury Association(ASIA) Score
Measured: 1 week, 3 months, 6 months, 12 months post operation
Modified Aminoff & Logue's Scale (mALS)
Measured: 1 week, 3 months, 6 months, 12 months post operation
Modified Denis Pain and Numbness Scale (mDPNS)
Measured: 1 week, 3 months, 6 months, 12 months post operation
Incidence of perioperative complications
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start1 Dec 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Vascular DiseasesStudies 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
- 380 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hongqi Zhang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University General Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital, General Hospital of Chinese Armed Police Forces, Beijing Haidian Hospital, China Rehabilitation Research Center
- Responsible party
- Sponsor-investigator, Hongqi Zhang, MD, Xuanwu Hospital, Beijing
- Investigators
- Zhang Hongqi, MD, Study director, Neurosurgical Department, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024749
- Sponsor's protocol ID
- D161100003816001
- Acronym
- SUIT-SAVM
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.
PubMed 25028446Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.
PubMed 25175433Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.
PubMed 23096418Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.
PubMed 23615108
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03024749
- Acronym / sponsor ID
- SUIT-SAVM / D161100003816001
- Conditions
- Spinal Cord Vascular Diseases
- Keywords
- Spinal Arteriovenous Malformation, Spinal Arteriovenous Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Hongqi Zhang, MDUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Tsinghua Chang Gung Hospital, Tianjin Medical University General Hospital, Peking University Third Hospital, Chinese PLA General Hospital, Beijing Hospital, General Hospital of Chinese Armed Police Forces, Beijing Haidian Hospital, China Rehabilitation Research Center
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Jan 2017 (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.
Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex neurosurgical lesions that are very challenging to manage. Spinal vascular malformations account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our understanding of these lesions has dramatically increased thanks to neuroimaging technology (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities including conservative observation, endovascular embolization, microsurgical resection, radiation therapy, and combined therapies have been reported. The treatment for these AVMs and AVFs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. Due to the rarity of these spinal vascular lesions, reports of their management and outcomes have been limited to small series and case reports. And the rates of obliteration and outcomes are not satisfactory, especially the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for the treating neurosurgeon.The purpose of this study is to establish multimodality treatment mode and evaluate the anatomical cure rate and functional preservation rate.
Detailed description
This is a multicenter, prospective, observational, registration study. There are nine centers involved in the study. The investigators set up a more detailed classification system for spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria, this cohort study will include 380 samples in the study period of three years. According to the spinal angiography, the correct diagnosis and treatment strategy will be made. The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients will be visited a total of four times, postoperative day 1 and postoperative day 7, followed up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function will be assessed objectively. All data will be recorded in the network database platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with spinal AVMs/AVFs
Key inclusion criteria (13 listed)
- patient diagnosed with spinal vascular diseases including
- patient not received surgical or interventional treatment before
- patient with normal cardiac, renal and hepatic function
- patient capable of understanding the content of the patient information / Informed Consent Form
- patient willing and able to participate in the registry
Key exclusion criteria (7 listed)
- patient received surgical treatment or interventional treatment before
- patient is pregnant
- patient allergic to iodine
- patient unable to complete follow-up
- patient with cerebral lesions
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
Change of the spinal cord function
Time frame: 1 day before operation and 12 months postoperative
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.
5 secondary outcomes
Anatomic obliteration rate
Time frame: 3 months post operation
American Spinal Injury Association(ASIA) Score
Time frame: 1 week, 3 months, 6 months, 12 months post operation
Modified Aminoff & Logue's Scale (mALS)
Time frame: 1 week, 3 months, 6 months, 12 months post operation
Modified Denis Pain and Numbness Scale (mDPNS)
Time frame: 1 week, 3 months, 6 months, 12 months post operation
Incidence of perioperative complications
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Background: PubMed 25028446Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.
- Background: PubMed 25175433Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.
- Background: PubMed 23096418Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.
- Background: PubMed 23615108Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.
- 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.
Zhang Hongqi, MD study director
Neurosurgical Department, Xuanwu Hospital, Beijing
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 Spinal Cord Vascular Diseases, run by Hongqi Zhang, MD 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 13 inclusion and 7 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 6 Jun 2017. 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?
Contact Hong Tao, MD (86-13810000653, hongtao.edu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the spinal cord function (time frame: 1 day before operation and 12 months postoperative). 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 NCT03024749, which also lists 4 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 6 Jun 2017.