Study on the Long-term Outcomes of High-level Cerebral Arteriovenous Malformation

Status: Unknown
Location: See location...
Study Type: Observational
SUMMARY

Arteriovenous malformations (AVMs) are complex and rare cerebral vascular dysplasia. The main purpose of treatment is to avoid the neurological impairment caused by hemorrhagic stroke. The Spetzler-Martin (SM) grading system is widely used to estimate the risk of postoperative complication based on maximum AVM nidus diameter, pattern of venous drainage, and eloquence of location. Generally, grade I and II are amenable to surgical resection alone. Grade III is typically treated via a multimodal approach, including microsurgical resection, embolization, and radiosurgery (SRS). Grade IV and V are generally observed unless ruptured. However, some previous studies indicated that despite the high rate of poor outcomes for high-level unruptured AVMs, the mortality for high-level unruptured AVMs are likely lower than untreated patients. With the development of new embolic materials and new intervention strategies, patients with high-level AVMs may have more opportunities to underwent more aggressive interventions. The OHAVM study aims to clarify the clinical outcomes for patients with SM grade IV and V AVMs after different management strategies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
View:

• The diagnosis of AVM was confirmed with digital subtraction angiography (DSA) and/or magnetic resonance imaging(MRI).

• The SM grade was IV and V.

Locations
Other Locations
China
Capital medical university affiliated Beijing Tiantan hospital
RECRUITING
Beijing
Contact Information
Primary
Yu Chen, MD
chenyu_tiantan@126.com
8618801239327
Backup
Yuanli Zhao, MD
zhaoyuanli@126.com
86-010-59978478
Time Frame
Start Date: 2012-04-01
Completion Date: 2024-12
Participants
Target number of participants: 1000
Treatments
Conservative management
Patients refused to accept any interventional treatment or patients were not suitable for any interventional treatment.
Microsurgical resection
All microsurgical procedures were performed with intraoperative neuronavigation, ultrasonography, indocyanine fluorescence angiography (ICG), continuous monitoring of electroencephalogram and somatosensory evoked potential.
Embolization
Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Multi-stage embolization and target embolization were widely used within the embolization. Onyx was the main embolization material.
Embolization+Radiosurgery
Embolization or radiosurgery was recommended as a priority for lesions located in deep functional locations such as brainstem and basal ganglia. Radiosurgery management was recommended for the residual lesions about 3 months after the embolization if necessary.
Single-stage hybrid surgery
Hybrid surgery is a new surgical strategy defined as single-stage combined microsurgical resection and embolization in which embolization is performed firstly on the deep feeding artery, aneurysm, AVF, and meningeal arteries involved in blood supply of the nidus, and then, the microsurgical resection was performed immediately. Intraoperative angiography was performed repeatedly before the skull was closed, confirming complete occlusion of the malformation.
Sponsors
Collaborators: Peking University International Hospital
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov