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

Beijing Tiantan Hospital1 site in 1 country1,000 target enrollmentApril 1, 2012

ConditionsArteriovenous Malformation of Brain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arteriovenous Malformation of Brain
Sponsor: Beijing Tiantan Hospital
Enrollment: 1000
Locations: 1
Primary Endpoint: modified Ranking Scale score at the last follow-up
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 1, 2012

End Date

December 2024

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Beijing Tiantan Hospital

Responsible Party

Principal Investigator

yuanli Zhao

Director of Department of Cerebrovascular Neurosurgery

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patients with multiple AVMs.
•Patients with hereditary hemorrhagic telangiectasia (HHT).
•Patients with missing clinical and imaging data.

Outcomes

Primary Outcomes

modified Ranking Scale score at the last follow-up

Time Frame: up to 10 years after the operation

The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

modified Ranking Scale score at 2 weeks after the operation

Time Frame: 2 weeks after operation

modified Ranking Scale score at 1 year after the operation

Time Frame: 1 year after operation

Long-term hemorrhagic rate

Time Frame: Conservative group: from the diagnosis to the last follow-up (up to 10 years); Intervention group: from 2 weeks after the operation to the last follow-up (up to 10 years)

For conservative group, the observation period was from the diagnosis to the last follow-up. For the intervention group, to rule out the influence of transient unstable blood flow in the perioperative period, the observation period was defined as from 2 weeks after the operation to the last follow-up.

modified Ranking Scale score at 3 years after the operation

Time Frame: 3 years after operation

modified Ranking Scale score at 5 years after the operation

Time Frame: 5 years after the operation