Brain Diseases, Cerebral Arteriovenous Malformation, Intra Cerebral Hemorrhage, Intracranial Aneurysm, Intracranial Arterial Diseases
Conditions
Keywords
Hemodynamic Mechanisms, Prospective cohort study, Endovascular treatment, Cerebral Arteriovenous Malformation, Intracranial Aneurysm
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.
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.
Interventions
None listed
Sponsors
Duan Chuanzhi
Beijing Tiantan Hospital
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
Shenzhen Second People's Hospital
Guangdong 999 Brain Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging Treatment Success Rate of Target Vascular Lesions | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perioperative complications | Perioperative period | Perioperative complications include technical related complications (vascular rupture, thrombosis, etc.) and clinical complications (neurological deficits, infections, etc.) |
| Proportion of patients with hemorrhagic complications during follow-up period | 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. |
| Proportion of patients with poor functional prognosis | 3 months postoperatively, 6 months postoperatively,and one year postoperatively | mRS score 3-6 |
| Proportion of patients with good functional prognosis | 3 months postoperatively, 6 months postoperatively,and one year postoperatively | mRS score 0-2 |
Countries
China
Contacts
CONTACTXin Feng, MD
PRINCIPAL_INVESTIGATORChuanzhi Duan, MD
Zhujiang Hospital
Outcome results
None listed