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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01803685
Recruitment Status : Unknown
Verified March 2013 by Dr. Yong Cao, Beijing Tiantan Hospital.
Recruitment status was:  Recruiting
First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Tracking Information
First Submitted Date March 1, 2013
First Posted Date March 4, 2013
Last Update Posted Date March 4, 2013
Study Start Date February 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2013)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 1, 2013)
Treatment complications [ Time Frame: six months after treatment ]
Post operative epilepsy seizure, hemorrhage,infarction;cerebral edema、endovascular embolization injury
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China
Official Title A Nationwide Treatment Survey of Intracranial Arteriovenous Malformation: a Multicenter Retrospective and Prospective Register Study in China
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All the patients that diagnosed of intracranial AVM by DSA/CT/MRI
Condition Intracranial Arteriovenous Malformations
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 1, 2013)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01803685
Other Study ID Numbers IAVM-125R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Yong Cao, Beijing Tiantan Hospital
Study Sponsor Dr. Yong Cao
Collaborators Not Provided
Investigators
Study Chair: Shuo Wang, MD Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date March 2013