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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Beijing Tiantan Hospital
Sponsor:
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT01803685
First received: March 1, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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
Intracranial Arteriovenous Malformations

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beijing Tiantan Hospital:

Primary Outcome Measures:
  • modified Ranking Scale [ Time Frame: six months after operation ] [ Designated as safety issue: No ]

    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:
  • Treatment complications [ Time Frame: six months after treatment ] [ Designated as safety issue: No ]
    Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury


Estimated Enrollment: 1000
Study Start Date: February 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803685

Locations
China, Beijing
Department of Neurosurgery, Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, MD    8610 67096510    caoyong6@hotmail.com   
Principal Investigator: Shuo Wang, MD         
Sponsors and Collaborators
Dr. Yong Cao
Investigators
Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
  More Information

No publications provided

Responsible Party: Dr. Yong Cao, no, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT01803685     History of Changes
Other Study ID Numbers: IAVM-125R
Study First Received: March 1, 2013
Last Updated: March 1, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Tiantan Hospital:
Intracranial Arteriovenous Malformations
Surgical removal
Endovascular embolism
Stereotaxic radiosurgery
Outcomes

Additional relevant MeSH terms:
Arteriovenous Malformations
Congenital Abnormalities
Hemangioma
Intracranial Arteriovenous Malformations
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Central Nervous System Vascular Malformations
Cerebrovascular Disorders
Intracranial Arterial Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Nervous System Diseases
Nervous System Malformations
Vascular Diseases
Vascular Malformations

ClinicalTrials.gov processed this record on October 23, 2014