Cerebral Arteriovenous MalformationNCT07353736
Cerebral Arteriovenous Malformation With Aneurysm: Epidemiology, Clinical Features, and Prognosis
An observational study of Cerebral Arteriovenous Malformation and Intracranial Arterial Diseases, run by Duan Chuanzhi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Arteriovenous Malformation, Intracranial Arterial Diseases, Intra Cerebral Hemorrhage
- How many people
- 630 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 528400
Xin Feng, MD, 13681134001 ext. +86, 13681134001@163.com
About this study
Official title: Hemodynamic Mechanisms, Clinical Profiles, and Prognostic Factors in Patients With Cerebral Arteriovenous Malformations and Intracranial Aneurysms: An Observational Cohort Study
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.
Read the 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.
- 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
- Medical subject headings
- Intracranial Arteriovenous Malformations, Intracranial Arterial Diseases, Cerebral Hemorrhage, Intracranial Aneurysm, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively
Secondary outcomes (4)
Incidence of perioperative complications
Perioperative complications include technical related complications (vascular rupture, thrombosis, etc.) and clinical complications (neurological deficits, infections, etc.)
Measured: Perioperative period
Proportion of patients with hemorrhagic complications during follow-up period
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.
Measured: within three years
Proportion of patients with poor functional prognosis
mRS score 3-6
Measured: 3 months postoperatively, 6 months postoperatively,and one year postoperatively
Proportion of patients with good functional prognosis
mRS score 0-2
Measured: 3 months postoperatively, 6 months postoperatively,and one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arteriovenous MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Duan Chuanzhi
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Duan Chuanzhi, Zhujiang Hospital
- Investigators
- Chuanzhi Duan, MD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353736
- Sponsor's protocol ID
- LC2016ZD032
- Status last verified
- Oct 2025
- First submitted
- 8 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Mechanisms, Clinical Profiles, and Prognostic Factors in Patients With Cerebral Arteriovenous Malformations and Intracranial Aneurysms: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07353736
- Acronym / sponsor ID
- LC2016ZD032
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Duan ChuanzhiUniversity, hospital or other
- Collaborators
- 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 start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuanzhi Duan, MD principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arteriovenous Malformation and Intracranial Arterial Diseases, run by Duan Chuanzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Feng, MD (13681134001 ext. +86, 13681134001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging Treatment Success Rate of Target Vascular Lesions (time frame: 3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.