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NCT Number: NCT07353736

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Imaging Treatment Success Rate of Target Vascular Lesions

    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.

Secondary outcomes

  1. Incidence of perioperative complications

    Time frame: Perioperative period

    Perioperative complications include technical related complications (vascular rupture, thrombosis, etc.) and clinical complications (neurological deficits, infections, etc.)

  2. Proportion of patients with hemorrhagic complications during follow-up period

    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.

  3. Proportion of patients with poor functional prognosis

    Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively

    mRS score 3-6

  4. Proportion of patients with good functional prognosis

    Time frame: 3 months postoperatively, 6 months postoperatively,and one year postoperatively

    mRS score 0-2

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Feng, MD

CONTACT

[email protected]

13681134001 ext. +86

Sponsors and collaborators

Lead sponsor

Duan Chuanzhi

Other

Collaborators

  • Beijing Tiantan Hospital
  • Guangdong 999 Brain Hospital
  • Second Affiliated Hospital of Nanchang University
  • Shenzhen Second People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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