Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas

NCT03024749 | Unknown DMC

• 1 other identifier: D161100003816001
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Vascular Diseases

Keywords

Spinal Arteriovenous Malformation; Spinal Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anatomic obliteration rate

  3 months post operation

• American Spinal Injury Association(ASIA) Score

  1 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 complications

  1 week

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with spinal AVMs/AVFs

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hongqi Zhang, MD: lead
• Beijing Tiantan Hospital: collaborator
• Beijing Tsinghua Chang Gung Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Peking University Third Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Beijing Hospital: collaborator
• General Hospital of Chinese Armed Police Forces: collaborator
• Beijing Haidian Hospital: collaborator
• China Rehabilitation Research Center: collaborator

Study Sites (1)

Tao Hong

Beijing, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 25028446 BACKGROUND

• 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.

  PMID: 25175433 BACKGROUND

• 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.

  PMID: 23096418 BACKGROUND

• 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.

  PMID: 23615108 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Vascular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhang Hongqi, MD

  Neurosurgical Department, Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Hong Tao, MD

CONTACT

86-13810000653; hongtao.edu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Neurosurgery

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 19, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

CN (1)