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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Incidence of perioperative complications
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
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
mRS score 3-6
Proportion of patients with good functional prognosis
mRS score 0-2
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
This trial is not recruiting at the moment. You can still explore other options: