Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China

• Conditions: Intracranial Arteriovenous Malformations

• Registration Number: NCT01803685
• Lead Sponsor: Dr. Yong Cao

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.

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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-03
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Study First Posted: 2013-03-04
• Last Update Posted: 2013-03-04
• Primary Completion: 2015-06
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Ranking Scale	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

Name	Time	Method
Treatment complications	six months after treatment	Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury

Trial Locations

Locations (1)

Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China