Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

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.

Arms, Groups and 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

Clinical Trial Outcome Measures

Primary Measures

  • 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. – 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Yong Cao
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Yong Cao, – Beijing Tiantan Hospital
  • Overall Official(s)
    • Shuo Wang, MD, Study Chair, Beijing Tiantan Hospital

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