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Not yet recruiting NCT07353736

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

— Observational Cerebral Arteriovenous Malformation Intracranial Arterial Diseases Intra Cerebral Hemorrhage Intracranial Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Arteriovenous Malformation, Intracranial Arterial Diseases, Intra Cerebral Hemorrhage, Intracranial Aneurysm. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Imaging Treatment Success Rate of Target Vascular Lesions [Time frame: 3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively]
Secondary outcome measures (4)
  • Incidence of perioperative complications [Time frame: Perioperative period]
  • Proportion of patients with hemorrhagic complications during follow-up period [Time frame: within three years]
  • Proportion of patients with poor functional prognosis [Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively]
  • Proportion of patients with good functional prognosis [Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhujiang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT07353736 · LC2016ZD032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗