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Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas

Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03024749
Acronym
SUIT-SAVM
Enrollment
380
Registered
2017-01-19
Start date
2016-12-01
Completion date
2019-12-31
Last updated
2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Vascular Diseases

Keywords

Spinal Arteriovenous Malformation, Spinal Arteriovenous Fistula

Brief 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. 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.

Interventions

None listed

Sponsors

Beijing Tiantan Hospital
CollaboratorOTHER
Beijing Tsinghua Chang Gung Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
General Hospital of Chinese Armed Police Forces
CollaboratorOTHER
Beijing Haidian Hospital
CollaboratorOTHER
China Rehabilitation Research Center
CollaboratorOTHER_GOV
Hongqi Zhang, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patient diagnosed with spinal vascular diseases including * intradural arteriovenous malformation, * intradural arteriovenous fistula, * dural arteriovenous fistula, * extradural arteriovenous malformation, * paravertebral arteriovenous malformation, * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change of the spinal cord function1 day before operation and 12 months postoperativeAmerican 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.

Secondary

MeasureTime frameDescription
Anatomic obliteration rate3 months post operationthe anatomic obliteration rate is determined by angiography 3 months post operation.
American Spinal Injury Association(ASIA) Score1 week, 3 months, 6 months, 12 months post operation
Modified Aminoff & Logue's Scale (mALS)1 week, 3 months, 6 months, 12 months post operation
Modified Denis Pain and Numbness Scale (mDPNS)1 week, 3 months, 6 months, 12 months post operation
Incidence of perioperative complications1 week

Countries

China

Contacts

Primary ContactHong Tao, MD
hongtao.edu@gmail.com86-13810000653

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026