Clinical trial NCT04136860: Long-term Outcomes After Different Management Strategies for High-level Cerebral Arteriovenous Malformation
Official title: Study on the Long-term Outcomes of High-level Cerebral Arteriovenous Malformation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Malformation of Brain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
First posted: 2019-10-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Spetzler-Martin (SM) grade IV and V brain arteriovenous malformation.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: modified Ranking Scale score at 2 weeks after the operation
timeFrame: 2 weeks after operation
measure: modified Ranking Scale score at 1 year after the operation
timeFrame: 1 year after operation
measure: modified Ranking Scale score at 3 years after the operation
timeFrame: 3 years after operation
measure: modified Ranking Scale score at 5 years after the operation
timeFrame: 5 years after the operation
measure: modified Ranking Scale score at the last follow-up
timeFrame: up to 10 years after the operation
measure: Long-term hemorrhagic rate
timeFrame: 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)
Secondary outcomes:
measure: Obliteration rate
timeFrame: At least 3 years, up to 10 years
Other outcomes:
measure: Incidence of postoperative epilepsy
timeFrame: 2 weeks and 1 years after the operation and the last follow-up (up to 10 years)
measure: Incidence of perioperative hemorrhage
timeFrame: 2 weeks after the operation
measure: Incidence of perioperative infarction
timeFrame: 2 weeks after the operation
measure: Incidence of endovascular embolization injury
timeFrame: 2 weeks after the operation
measure: Incidence of radiation necrosis
timeFrame: Half a year and 1 years after the operation and the last follow-up (up to 10 years)
Locations:
city: Beijing
country: China
facility: Capital medical university affiliated Beijing Tiantan hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen Y, Li R, Ma L, Meng X, Yan D, Wang H, Ye X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-term outcomes of brainstem arteriovenous malformations after different management modalities: a single-centre experience. Stroke Vasc Neurol. 2021 Mar;6(1):65-73. doi: 10.1136/svn-2020-000407. Epub 2020 Sep 14.
citation: Chen Y, Li R, Ma L, Zhao Y, Yu T, Wang H, Ye X, Wang R, Chen X, Zhao Y. Single-Stage Combined Embolization and Resection for Spetzler-Martin Grade III/IV/V Arteriovenous Malformations: A Single-Center Experience and Literature Review. Front Neurol. 2020 Oct 29;11:570198. doi: 10.3389/fneur.2020.570198. eCollection 2020.
citation: Chen Y, Yan D, Li Z, Ma L, Zhao Y, Wang H, Ye X, Meng X, Jin H, Li Y, Gao D, Sun S, Liu A, Wang S, Chen X, Zhao Y. Long-Term Outcomes of Elderly Brain Arteriovenous Malformations After Different Management Modalities: A Multicenter Retrospective Study. Front Aging Neurosci. 2021 Feb 18;13:609588. doi: 10.3389/fnagi.2021.609588. eCollection 2021.