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

March 1, 2013 updated by: Dr. Yong Cao

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients that diagnosed of intracranial AVM by DSA/CT/MRI

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
six months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment complications
Time Frame: six months after treatment
Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury
six months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Yong Cao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

September 1, 2015

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (ESTIMATE)

March 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAVM-125R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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