Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 528400, China
NCT Number: NCT07353736
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.
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Observational
Guangzhou, Guangdong, 528400, China
This study aims to evaluate the clinical safety and efficacy of different treatment strategies in patients with cerebral arteriovenous malformations (AVMs) combined with intracranial aneurysms (IAs) through a multicenter, large-sample, prospective observational cohort study. It will comprehensively analyze the epidemiological characteristics, clinical manifestations, associated risk factors, natural disease progression, and bleeding risks, as well as explore the hemodynamic mechanisms and genetic background differences. Clinical data, imaging findings, and blood samples will be collected from patients to investigate the impact of hemodynamics on aneurysm formation, rupture risk, and treatment outcomes. Additionally, the study will explore the genetic differences of AVM and IA patients and their correlation with clinical presentation and prognosis, ultimately providing a scientific basis for individualized treatment strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: Perioperative period
Perioperative complications include technical related complications (vascular rupture, thrombosis, etc.) and clinical complications (neurological deficits, infections, etc.)
Time frame: within three years
Including the type of bleeding (intracerebral hemorrhage/subarachnoid hemorrhage/intraventricular hemorrhage), specific location of bleeding,amount of bleeding;and determination of bleeding source: determine the source of bleeding from malformation or aneurysm through imaging examination.
Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively
mRS score 3-6
Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively
mRS score 0-2
Contact information is provided by the study sponsor or research team.
Duan Chuanzhi
Other
Hemodynamic Mechanisms, Clinical Profiles, and Prognostic Factors in Patients With Cerebral Arteriovenous Malformations and Intracranial Aneurysms: An Observational Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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