NCT04136860

Long-term Outcomes After Different Management Strategies for High-level Cerebral Arteriovenous Malformation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Follow-up: In our neurosurgical center, follow-up was conducted for all patients at the first 3-6 months and annually after discharge by clinical visit and telephone interview. Study overview: The population in the OHAVM study will be divided into two parts. Clinical and imaging data of high-level AVM patients from 2012/04 to 2019/09 were retrospectively collected. And the high-level AVM patients from 2019/09 to 2019/12 were prospectively collected. The intervention strategies in our institution for high-level AVMs are of four categories: microsurgical resection, embolization, embolization+radiosurgery, and single-stage hybrid surgery (embolization-resection). Each participants will be followed at least for 5 year since enrollment. Finally, we will clarify the clinical outcomes and prognostic predictors for patients with SM grade IV and V AVMs after different management strategies. Sample size: About 1000 patients will be enrolled in this study, and half of them were unruptured. The population distribution of different management strategies is expected as follows: conservative:100 cases, microsurgical resection: 300 cases, embolization:250 cases, embolization+radiosurgery: 250 cases, single-stage hybrid surgery: 100 cases. Study endpoints: The neurological function prognosis, occlusion rate and complications were evaluated at 2 weeks, 1 year, 3 years, 5 years after the treatment and the last follow-up, respectively.

Conditions

• Arteriovenous Malformation of Brain

Timeline

• Start date: 2012-04-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2019-10-23
• Last updated: 2020-11-30

Locations

1 site across 1 country: China