Spinal Cord Vascular Diseases Clinical Trial
— SUIT-SAVMOfficial 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.
| Status | Recruiting |
| Enrollment | 380 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Tao Hong | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Hongqi Zhang, MD | Beijing Haidian Hospital, Beijing Hospital, Beijing Tiantan Hospital, Beijing Tsinghua Chang Gung Hospital, China Rehabilitation Research Center, Chinese PLA General Hospital, General Hospital of Chinese Armed Police Forces, Peking University Third Hospital, Tianjin Medical University General Hospital |
China,
Gross 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. — View Citation
Gross 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. — View Citation
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. — View Citation
Rangel-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1 day before operation and 12 months postoperative | |
| Secondary | Anatomic obliteration rate | the anatomic obliteration rate is determined by angiography 3 months post operation. | 3 months post operation | |
| Secondary | American Spinal Injury Association(ASIA) Score | 1 week, 3 months, 6 months, 12 months post operation | ||
| Secondary | Modified Aminoff & Logue's Scale (mALS) | 1 week, 3 months, 6 months, 12 months post operation | ||
| Secondary | Modified Denis Pain and Numbness Scale (mDPNS) | 1 week, 3 months, 6 months, 12 months post operation | ||
| Secondary | Incidence of perioperative complications | 1 week |