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

Arteriovenous Malformation of Brain Clinical Trial

— OHAVM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136860
• Other study ID #: KY 2019-09-15
• Status: Recruiting
• Start date: April 1, 2012
• Est. completion date: December 2024

Study information

• Verified date: November 2020
• Source: Beijing Tiantan Hospital
• Contact: Yu Chen, MD
• Phone: 8618801239327
• Email: chenyu_tiantan[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformation of Brain
• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Locations

Country	Name	City	State
China	Capital medical university affiliated Beijing Tiantan hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Peking University International Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. 2 — View 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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of postoperative epilepsy	It can only be diagnosed as postoperative epilepsy with the evidence of typical convulsions and other systemic seizures or EEG evidence.	2 weeks and 1 years after the operation and the last follow-up (up to 10 years)
Other	Incidence of perioperative hemorrhage	Bleeding within two weeks after the operation may be related to the redistribution of cerebral blood flow. The diagnosis of perioperative hemorrhage requires CT confirmation.	2 weeks after the operation
Other	Incidence of perioperative infarction	Perioperative infarction within two weeks after the operation may be related to the redistribution of cerebral blood flow. The diagnosis of perioperative infarction requires CT confirmation or MRI confirmation.	2 weeks after the operation
Other	Incidence of endovascular embolization injury	Endovascular embolization injuries include arterial dissection, catheter failure, etc.	2 weeks after the operation
Other	Incidence of radiation necrosis	Radiation necrosis usually starts to appear within half a year after gamma knife operation. MRI evidence is needed to diagnose radiation necrosis.	Half a year and 1 years after the operation and the last follow-up (up to 10 years)
Primary	modified Ranking Scale score at 2 weeks after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead	2 weeks after operation
Primary	modified Ranking Scale score at 1 year after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead	1 year after operation
Primary	modified Ranking Scale score at 3 years after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead	3 years after operation
Primary	modified Ranking Scale score at 5 years after the operation	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead	5 years after the operation
Primary	modified Ranking Scale score at the last follow-up	The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead	up to 10 years after the operation
Primary	Long-term hemorrhagic rate	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.	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	Obliteration rate	Confirmed by postoperative DSA or MRI/MRA	At least 3 years, up to 10 years