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

NCT07353736 | Not Yet Recruiting DMC

• 1 other identifier: LC2016ZD032
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Arteriovenous Malformation; Intracranial Arterial Diseases; Intra Cerebral Hemorrhage; Intracranial Aneurysm; Brain Diseases

Keywords

Hemodynamic Mechanisms; Prospective cohort study; Endovascular treatment; Cerebral Arteriovenous Malformation; Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of perioperative complications

  Perioperative period

• Proportion of patients with hemorrhagic complications during follow-up period

  within three years

• Proportion of patients with poor functional prognosis

  3 months postoperatively, 6 months postoperatively,and one year postoperatively

• Proportion of patients with good functional prognosis

  3 months postoperatively, 6 months postoperatively,and one year postoperatively

Study Arms (1)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Shenzhen Second People's Hospital: collaborator
• Guangdong 999 Brain Hospital: collaborator
• Duan Chuanzhi: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Zhujiang Hospital, Southern Medical University

Guangzhou, Guangdong, 528400, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from patients with different types of cerebral arteriovenous malformations combined with intracranial aneurysms

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations; Intracranial Arterial Diseases; Cerebral Hemorrhage; Intracranial Aneurysm; Brain Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aneurysm

Study Officials

• Chuanzhi Duan, MD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Feng, MD

CONTACT

13681134001; 13681134001@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: January 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)