NTSIAVMC: Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China

Sponsor

Dr. Yong Cao (Other)

Overall Status

Unknown status

CT.gov ID

NCT01803685

Collaborator

(none)

1,000

Enrollment

Location

30.9

Duration (Months)

32.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

modified Ranking Scale [six months after operation]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead

Secondary Outcome Measures

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