- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543472
Dural Arteriovenous Fistulas Research at China INI
Study Overview
Status
Conditions
Detailed Description
Title:Dural Arteriovenous Fistulas Research at China INI.
Purpose:The incidence of DAVF is low. By collecting clinical data, we aim to establish a comprehensive database and biobank. This will help us elucidate the potential pathogenesis, vascular architecture, biological markers, and treatment outcomes of DAVFs. Furthermore, this study aims to address current controversies (such as treatment strategies for DAVF with pial arterial supply), unresolved issues (such as the optimal treatment and prognosis of infantile type DAVF), and further explore possible mechanisms of DAVF development.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Beijing, China
- Xuanwu Hospital, Capital Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients with DAVFs who were admitted to Xuanwu Hospital.
Exclusion Criteria:
- Non-DAVF lesions confirmed by DSA.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Long term prognosis
Time Frame: assessed at 3, 6, 12 and 24 months after procedure
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Safety endpoints include perioperative and postoperative complications, as well as the clinical status of the patients.
This is evaluated using the preoperative modified Rankin Scale (mRS), mRS at discharge, and mRS at 6 to 12 months, along with the most recent clinical (inpatient/outpatient) or telephone follow-up.
Efficacy endpoints include the immediate DAVF occlusion status after the last treatment, and the results from imaging follow-ups (DSA/MRA/CTA) at 6 to 12 months and the latest follow-up.
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assessed at 3, 6, 12 and 24 months after procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term cure rate
Time Frame: assessed at 3, 6, 12 and 24 months after procedure
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The recurrence rate of DAVF after confirmed complete cure, as determined by DSA/MRA/CTA
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assessed at 3, 6, 12 and 24 months after procedure
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hongqi Zhang, MD, Xuanwu Hospital Department of Neurosurgery
- Principal Investigator: Xin Su, MD, Xuanwu Hospital Department of Neurosurgery
- Principal Investigator: Zihao Song, MD, Xuanwu Hospital Department of Neurosurgery
- Principal Investigator: Huiwei Liu, MD, Xuanwu Hospital Department of Neurosurgery
- Study Director: Peng Zhang, MD, Xuanwu Hospital Department of Neurosurgery
- Study Director: Yongjie Ma, MD, Xuanwu Hospital Department of Neurosurgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XW0630
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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