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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Feng, MD | Contact | 13681134001 | +86 | 13681134001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanzhi Duan, MD | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong | 528400 | China |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| D020765 | Intracranial Arterial Diseases |
| D002543 | Cerebral Hemorrhage |
| D002532 | Intracranial Aneurysm |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
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| Second Affiliated Hospital of Nanchang University |
| OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Guangdong 999 Brain Hospital | OTHER |
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Blood samples from patients with different types of cerebral arteriovenous malformations combined with intracranial aneurysms
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 |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000783 | Aneurysm |