Cerebral Arteriovenous Malformation With Aneurysm: Epidemiology, Clinical Features, and Prognosis

Hemodynamic Mechanisms, Clinical Profiles, and Prognostic Factors in Patients With Cerebral Arteriovenous Malformations and Intracranial Aneurysms: An Observational Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Diseases; Intracranial Arterial Diseases; Intra Cerebral Hemorrhage; Intracranial Aneurysm; Cerebral Arteriovenous Malformation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 630

Contacts and Locations

• Study Contact: Name: Xin Feng, MD; Phone Number: +86 13681134001; Email: 13681134001@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 528400
      • Zhujiang Hospital, Southern Medical University
      • Contact: Xin Feng, MD; Phone Number: +86 13681134001; Email: 13681134001@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated across eight neurosurgery centers who were confirmed by digital subtraction angiography (DSA), and/or magnetic resonance imaging (MRI), computed tomographic angiography (CTA) to have cerebral arteriovenous malformation and intracranial aneurysm.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients diagnosed with cerebral arteriovenous malformations and intracranial aneurysms; Patients diagnosed with concomitant cerebral arteriovenous malformations and intracranial aneurysms by digital subtraction angiography (DSA), and/or magnetic resonance imaging (MRI), and/or computed tomographic angiography (CTA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging Treatment Success Rate of Target Vascular Lesions	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.	3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative complications	Perioperative complications include technical related complications (vascular rupture, thrombosis, etc.) and clinical complications (neurological deficits, infections, etc.)	Perioperative period
Proportion of patients with hemorrhagic complications during follow-up period	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.	within three years
Proportion of patients with poor functional prognosis	mRS score 3-6	3 months postoperatively, 6 months postoperatively,and one year postoperatively
Proportion of patients with good functional prognosis	mRS score 0-2	3 months postoperatively, 6 months postoperatively,and one year postoperatively

Collaborators and Investigators

• Sponsor: Duan Chuanzhi
• Collaborators: The First Affiliated Hospital of Nanchang University; Beijing Tiantan Hospital; The First Affiliated Hospital of Zhengzhou University; Shenzhen Second People's Hospital; Second Affiliated Hospital of Nanchang University; Guangdong 999 Brain Hospital
• Investigators: Principal Investigator: Chuanzhi Duan, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Intracranial Aneurysm; Prospective cohort study; Endovascular treatment; Hemodynamic Mechanisms; Cerebral Arteriovenous Malformation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Congenital Abnormalities; Cardiovascular Abnormalities; Nervous System Malformations; Aneurysm; Intracranial Hemorrhages; Vascular Malformations; Arteriovenous Malformations; Central Nervous System Vascular Malformations; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Brain Diseases; Cerebral Hemorrhage; Intracranial Aneurysm; Intracranial Arteriovenous Malformations; Intracranial Arterial Diseases
• Other Study ID Numbers: LC2016ZD032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No