Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas

NCT ID: NCT03024749

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Spinal Cord Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

China Rehabilitation Research Center

OTHER_GOV

Sponsor Role collaborator

Hongqi Zhang, MD

OTHER

Sponsor Role lead

Responsible Party

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Hongqi Zhang, MD

Director of Neurosurgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhang Hongqi, MD

Role: STUDY_DIRECTOR

Neurosurgical Department, Xuanwu Hospital, Beijing

Locations

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Tao Hong

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Tao, MD

Role: CONTACT

86-13810000653

Facility Contacts

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Hong Tao, MD.

Role: primary

13810000653

References

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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.

Reference Type BACKGROUND
PMID: 25028446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25175433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23096418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23615108 (View on PubMed)

Other Identifiers

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D161100003816001

Identifier Type: -

Identifier Source: org_study_id

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