Diseases and Abnormalities at or Before Birth

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Heart and Blood Diseases

Neoplasms

Congenital Abnormalities

Arteriovenous Malformations

Hemangioma

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Onyx

TRUFILL

Gary Duckwiler, MD

Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%

Recent advances in the endovascular treatment of arteriovenous malformations (AVMs) have increased the number of patients with brain AVMs for whom embolization therapy may be appropriate. The permanency of obliterated nidi and occurrence of procedural complications are thought to be at least partially influenced by the characteristics of the material used, with liquid agents more likely to reach and occlude the AVM nidus compared to particulate embolic agents.

The only liquid embolic agent approved in the U.S. for the presurgical embolization of AVMs is TRUFILL®. TRUFILL n-butyl cyanoacrylate (n-BCA) is a liquid adhesive that polymerizes into a solid material upon contact with blood fluids or tissue, via an anionic mechanism. TRUFILL Ethiodized Oil is mixed into the n-BCA monomer as a radiopaque polymerizing retardant. TRUFILL Tantalum Powder may also be added for radiopacity. The TRUFILL n-BCA Liquid Embolic System received U.S. FDA premarket approval on September 25, 2000 (P990040) for use in the embolization of cerebral AVMs, when presurgical devascularization is desired.

Onyx™ is a non-adhesive liquid embolic agent comprised of ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO), and of micronized tantalum powder. Onyx precipitates into a solid on contact with blood fluids, due to rapid diffusion of the DMSO solvent. The Onyx Liquid Embolic System received the European "CE mark" in July 1999, and has been available outside of the U.S. since September 1999 for use in the embolization of AVMs.

The purpose of this randomized-controlled study is to obtain prospective clinical data on the performance of Onyx (investigational device) and TRUFILL (control device) in the presurgical embolization of brain AVMs. Device safety will be assessed by comparing overall and device-related morbidity and mortality. The primary efficacy endpoint is the angiographic reduction in AVM size (volume) achieved. The objective is to demonstrate that Onyx is no worse than TRUFILL within a specified clinical tolerance. Study results will be used to support a premarket approval application for Onyx in the presurgical embolization of brain AVMs.

Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)

U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)

Micro Therapeutics Inc.

Medtronic Neurovascular Clinical Affairs

Linda Simpson/Director of Clinical Affairs

Nervous System Diseases

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation.

Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.

An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.

one-staged hybrid operation

The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation

Traditional microsurgical operation

Shuo Wang, MD

Jun Wu, MD

Guilin Li, MD

Weijian Jiang, MD

Donghai Wang, MD

Chuanfeng Li, MD

Liang Chen, MD

Gao Chen, MD

Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been challenges among cerebrovascular diseases. None of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bAVMs without a risk of neural function deterioration. The multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. The one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bAVMs. However, lacking the support of high-level evidence, its advantages remain unclear. This study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its indications, key technologies, and workflows.

The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists of 2 sets. The registry set is designed as a prospective real-world registry. The trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. The two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. The assignment is based on the clinical condition in the registry set and is randomized in the trial set. End points will be evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation in treating complex bAVMs will be validated.

Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations

Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations

any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications

the bAVMs residue revealed by postoperative DSA or computed tomographic angiography

Ministry of Science and Technology of the People´s Republic of China

Director of Neurosurgery Department

Laurence SALOMON, MD, PhD

Raphaël BLANC

Raphaël BLANC, MD

In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic).

This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations

Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)

Fondation Ophtalmologique Adolphe de Rothschild

Shaosen Zhang, Doctor

Dong Zhang, Doctor

Xinjian Yang, Doctor

Lebao Yu, Doctor

Yuanren Zhai, Doctor

Liangran Huang, Doctor

Wei Liu, Master

Jun Lu, Doctor

Yingwei Zhen, Doctor

Guosheng Zhou, Doctor

Zhiyong Shi, Doctor

Yongbo Yang, Doctor

Guosheng Zhou

Yongbo Yang

The purpose of this study is to investigate the role of multimodal CT in evaluating and predicting different clinical outcomes in patients with unruptured brain arteriovenous malformations with medical management alone.

This study will be undertaken in the following aspects:

1. Morphological, structural and imaging histological signal analysis based on multimodal CT to explore the relationship between imaging features and different clinical outcomes of bAVMs.
2. Hemodynamic and flow pattern analysis of local and peripheral bAVMs based on multimodal CT to explore the association between blood flow features and different clinical outcomes.
3. Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.

The obtained patient information includes: Baseline information, CT, MRI, DSA (Optional), and follow-up information. Follow-up will be undertaken at 6 months, 12 months, 24 months and 36 months after enrollment with the following primary observation.

Main observation endpoints:

1. Hemorrhage events associated with bAVMs
2. New epilepsy symptoms or exacerbations
3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc).

This study is a Long-term, multi-center, prospective registry study, and was supported by China National Key Research and Development Program Project No. 2021YFC2500502.

The purpose of this study is to investigate the role of multimodal Computer Tomography(CT) in evaluating and predicting different clinical outcomes in patients with unruptured brain arteriovenous malformations with medical management alone.

This study will be undertaken in the following aspects:

1. Morphological, structural and imaging histological signal analysis based on multimodal CT to study the relationship between imaging features and different clinical outcomes of bAVMs.
2. Hemodynamic and flow pattern analysis of local and peripheral bAVMs based on multimodal CT to explore the association between blood flow features and different clinical outcomes.
3. Based on multimodal CT and deep learning algorithms to create an automated segmentation model for bAVMs and a prediction model for distinct clinical outcomes.
4. To compare the efficacy of multimodal CT and MRI in evaluating the clinical outcomes of unruptured cerebral arteriovenous malformations.

The obtained patient information includes:

1. Baseline information
2. CT images: including non-contrast CT(NCCT), CT Angiography, CT perfusion
3. Magnetic Resonance Imaging(MRI): including T1-weighted image, T2-weighted image, T2-FLAIR, Time of Flight MR angiography(TOF-MRA), diffusion-weighted imaging(DWI), susceptibility weighted imaging(SWI)
4. Digital subtraction angiography(DSA, optional)
5. Follow-up information: follow-up will be undertaken at 6 months, 12 months, 24 months and 36 months after enrollment with the following primary observation.

Main observation endpoints:

1. Hemorrhage events associated with bAVMs, ensuring by CT scan;
2. New epilepsy symptoms or exacerbations, ensuring by consultation or EEG ;
3. New neurological dysfunction(including motor dysfunction, cognitive dysfunction, etc), ensuring by consultation, physical examination or any radiology examination.

Inclusion criteria

1. Patients with confirmed diagnosis of bAVMs in the cerebrum, basal ganglia, thalamus, corpus callosum, cerebellum and brainstem;
2. Patients with no history of previous bAVM related hemorrhage confirmed by CT examination, or have radiographic examination completed prior to the hemorrhage.
3. Patients with radiographic examinations before any treatment;

Exclusion criteria.

1. Patients with simple arteriovenous fistula;
2. Patients with combined dural arteriovenous fistula;
3. Arteriovenous malformations occurring in the spinal cord;
4. Pregnant patients were not included in this study.

Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT

Evaluation of Clinical Outcomes of Unruptured Brain Arteriovenous Malformations Treated With Medical Management Alone Based on Multimodal Computer Tomography: A Long-term Multicenter Prospective Cohort Study

Arteriovenous malformation rupture during follow-up before treatment

Progression of seizure symptoms during follow-up, including but not limited to more frequent seizures, worsening of symptoms, etc.

New neurological deficits during the follow-up period, including motor deficits, cognitive deficits, etc.

Patients receiving any form of intervention during the follow-up period will stop the follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)	NCT00857662	Brain Arteriove...	Onyx TRUFILL	-	Medtronic Neurovascular Clinical Affairs
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)	NCT00857662	Brain Arteriove...	Onyx TRUFILL	-	Medtronic Neurovascular Clinical Affairs
Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations	NCT03774017	Cerebrovascular... Arteriovenous M... Complex; Primar...	one-staged hybr... Traditional mic...	- 70 Years	Ministry of Science and Technology of the People´s Republic of China
Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations	NCT02896881	Brain Arteriove...		18 Years -	Fondation Ophtalmologique Adolphe de Rothschild
Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT	NCT05449106	Brain Arteriove...		3 Years - 80 Years	Beijing Tiantan Hospital
Evaluation of Clinical Outcomes of Unruptured bAVMs Treated With Medical Management Alone Based on Multimodal CT	NCT05449106	Brain Arteriove...		3 Years - 80 Years	Beijing Tiantan Hospital

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