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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorDuan Chuanzhi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

630 Participants
are grouped into 1 trial group
Group A: Patients diagnosed with cerebral arteriovenous malformations and intracranial aneurysms

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months postoperatively, 6 months postoperatively, 1years postoperatively, and 2 years postoperatively

Secondary outcomes

1

Incidence of perioperative complications

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

Time frame
Perioperative period
2

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.

Time frame
within three years
3

Proportion of patients with poor functional prognosis

mRS score 3-6

Time frame
3 months postoperatively, 6 months postoperatively,and one year postoperatively
4

Proportion of patients with good functional prognosis

mRS score 0-2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duan Chuanzhi

Lead sponsor

Zhujiang Hospital

Sponsor institution

Beijing Tiantan Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Second Affiliated Hospital of Nanchang University

Collaborator

Shenzhen Second People's Hospital

Collaborator

Guangdong 999 Brain Hospital

Collaborator

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