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Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China (NTSIAVMC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01803685
Recruitment Status : Unknown
Verified March 2013 by Dr. Yong Cao, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Brief Summary:
This register study will collect the treatment information of the intracranial arteriovenous malformation patients in China. We aim to understand the current treatment situation of the disease in China.

Condition or disease
Intracranial Arteriovenous Malformations

Detailed Description:

Intracranial arteriovenous malformations are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without intervening normal capillary bed. The treatment strategy including surgical removal, endovascular embolism and stereotaxic radiosurgery and comprehensive treatment. China is a united multi-ethnic nation of 56 ethnic groups, and has the largest population in the world. We have most extensive and valuable clinical resources of intracranial arteriovenous malformation in the world. But we know little about the current treatment situation of the disease in China.

In order to realize the treatment situation of intracranial arteriovenous malformation in China, we designed a retrospective and prospective register study to collect the treatment and outcome information all over China.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China
Study Start Date : February 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015

Surgical treatment
Surgical resection of intracranial arteriovenous malformations.
Stereotaxic radiosurgery
Deliver a relatively high dose of focused radiation precisely to the arteriovenous malformations.
Endovascular treatment
Deliver embolic materials to the feeding arteries or the nidus by microcatheters
Comprehensive treatment
Use two or three methods ( Surgical treatment stereotaxic radiosurgery endovascular treatment ) to cure the intracranial arteriovenous malformations
Conservative treatment
Patients refused to any of the treatment above

Primary Outcome Measures :
  1. modified Ranking Scale [ Time Frame: six months after operation ]

    The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead

Secondary Outcome Measures :
  1. Treatment complications [ Time Frame: six months after treatment ]
    Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the patients that diagnosed of intracranial AVM by DSA/CT/MRI

Inclusion Criteria:

  • All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
  • All patients gave written informed consent

Exclusion Criteria:

  • patients refuse to attend the survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01803685

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China, Beijing
Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, MD    8610 67096510   
Principal Investigator: Shuo Wang, MD         
Sponsors and Collaborators
Dr. Yong Cao
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Study Chair: Shuo Wang, MD Beijing Tiantan Hospital

Additional Information:

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Responsible Party: Dr. Yong Cao, , Beijing Tiantan Hospital Identifier: NCT01803685    
Other Study ID Numbers: IAVM-125R
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013
Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
Intracranial Arteriovenous Malformations
Surgical removal
Endovascular embolism
Stereotaxic radiosurgery
Additional relevant MeSH terms:
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Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases