Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China

Intracranial Arteriovenous Malformations Clinical Trial

— NTSIAVMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01803685
• Other study ID #: IAVM-125R
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2013
• Last updated: March 1, 2013
• Start date: February 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2013
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Locations

Country	Name	City	State
China	Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Yong Cao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Ranking Scale	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	six months after operation	No
Secondary	Treatment complications	Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema?endovascular embolization injury	six months after treatment	No