Clinical Trials in China / NCT07353736
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Observational
Cerebral Arteriovenous Malformation With Aneurysm: Epidemiology, Clinical Features, and Prognosis
NCT07353736 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cerebral Arteriovenous MalformationIntracranial Arterial DiseasesIntra Cerebral HemorrhageIntracranial AneurysmBrain Diseases
Study summary
The study is a multicenter, prospective cohort study designed to assess the natural history, clinical safety and efficacy of various treatment strategies in patients with cerebral arteriovenous malformations (AVMs) and intracranial aneurysms.
Eligibility
Inclusion Criteria:
* Patients diagnosed with cerebral arteriovenous malformation and intracranial aneurysm confirmed by CTA, MRA, and/or DSA;
* Availability of complete clinical and imaging data;
* Provision of written informed consent by the patient or their legally authorized representative to participate in the study and undergo follow-up;
* Not concurrently participating in any other clinical trials that may interfere with the outcomes of this study.
Exclusion Criteria:
* Previous complete occlusion of the aneurysm and/or arteriovenous malformation prior to enrollment;
* Coexistence of other cerebrovascular diseases such as moyamoya disease, cerebral cavernous malformation, cerebral venous sinus thrombosis, etc.;
* Absence of DSA imaging data or poor image quality that precludes accurate evaluation of key anatomical and hemodynamic parameters of the AVM and intracranial aneurysm.
Primary outcome measure(s)
- Imaging Treatment Success Rate of Target Vascular Lesions — 3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively
his is a composite endpoint with stratified reporting by lesion type. It will separately calculate and report the success rates for the following two patient cohorts: For patients with intracranial aneurysms: Treatment success is defined as complete occlusion on postoperative digital subtraction angiography, assessed as Class I by the Raymond-Roy Occlusion Classification (RROC) or as Grade D by the O'Kelly-Marotta (OKM) grading scale. For patients with cerebral arteriovenous malformations (AVMs): Treatment success is defined as complete embolization on postoperative digital subtraction angiography, confirmed by the core laboratory or two independent assessors with no residual nidus opacification. Critical clarification: This composite measure does NOT calculate an overall arithmetic combined success rate. The final reported values will be two independent percentages.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07353736 on ClinicalTrials.gov ↗ ← All trials in China