An interventional study of Standard Trans-Arterial Embolization (TAE) and Trans-Venous Embolization (TVE) in Arteriovenous Malformations, Cerebral, Unruptured Brain Arteriovenous Malformation and Ruptured Brain Arteriovenous Malformation, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 9 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
A new endovascular route for the treatment of brain AVMs may be possible in some cases: Trans-Venous Embolization (TVE). The technique uses microcatheters to navigate to the draining veins of AVM, to reach and then fill the AVM nidus retrogradely with liquid embolic agents until the lesion is occluded. This technique has the potential to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate. However, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of AVMs: to preserve the draining vein until all afferent vessels have been occluded. Nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications.
The method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. Care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.
43 studies on the registry are indexed under Intracranial Arteriovenous Malformations; 15 are open to participants now.
This study's enrollment of 77 is close to the median of 85 across 18 interventional studies indexed under Intracranial Arteriovenous Malformations.
Browse Intracranial Arteriovenous Malformations studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
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Contraindication
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard TAE, without TVE, is used in patient allocated standard treatment. The arterial approach will consist of at least one attempted catheterization for trans-arterial injection of liquid embolic. Patients incompletely treated at the time of the final embolization procedure are adjudicated a failure to reach the primary outcome and can be treated using alternative standard options (including surgery, radiation therapy, conservative management). In addition, patients of the control group can also be offered TVE, if still feasible, once the TAE has been adjudicated to be a failure. If the operator deems, on the table, for a trans-arterial injection to be too dangerous, no arterial injection is necessary. Treatment, where indicated, can be completed through other means.
Procedure: Standard Trans-Arterial Embolization (TAE)
The experimental treatment is an attempt to completely occlude the AVM using venous catheterization and retrograde EVOH injection during the final session. TAE can be performed to prepare for final TVE during the same or one previous preparatory session, or TAE can be used to rescue an incomplete TVE. In some patients, balloon catheterization is used trans-arterially to assist TVE. It will be permissible to perform more than one treatment session when deemed necessary (occasionally to treat an AVM through the trans-venous route requires a two-stage approach, with a single trans-arterial attempt to decrease AVM filling prior to the definitive trans-venous approach, and this will be permitted). The trans-venous strategy will consist of at least one transvenous injection of ethyl vinyl alcohol (EVOH), with the choice of delivery microcatheters and other technical details left to the individual operator's discretion).
Procedure: Trans-Venous Embolization (TVE)
The standard TAE, without TVE, is used in patient allocated standard treatment. The arterial approach will consist of at least one attempted catheterization for trans-arterial injection of liquid embolic. If the operator deems, on the table, for a trans-arterial injection to be too dangerous, no arterial injection is necessary. Treatment, where indicated, can be completed through other means.
The experimental treatment is an attempt to completely occlude the AVM using venous catheterization and retrograde EVOH injection during the final session. The trans-venous strategy will consist of at least one transvenous injection of ethyl vinyl alcohol (EVOH), with the choice of delivery microcatheters and other technical details left to the individual operator's discretion.
Angiographic evidence of residual AVM at time of confirmatory catheter angiography.
Angiographic evidence of residual AVM at time of confirmatory catheter angiography
Time frame: 3 months +/- 1 month following embolization
Failure to safely and effectively position the embolization microcatheter.
Failure to reach a safe and effective microcatheter position for embolization.
Time frame: within day of procedure
Any procedural complication leading to transient new neurological deficit.
Any procedural complication leading to transient new neurological deficit.
Time frame: <5 days
Any procedural complication leading to new neurological deficit.
Any procedural complication leading to new neurological deficit.
Time frame: ≥5 days
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Time frame: Within one week
Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
Time frame: within 5 days post procedure
Length of hospitalization (days).
Length of hospitalization (days).
Time frame: ≥5 days
Patient discharge to a location that is not his/her home.
Discharge to location other than home.
Time frame: through to 3 (+/- 1) months follow-up
mRS at discharge and 3(+/-1) months.
mRS at discharge and 3(+/-1) months.
Time frame: through to 3 (+/- 1) months follow-up
Incidence of new admission to hospital during follow-up.
Incidence of new admission to hospital during follow-up.
Time frame: Within 3 +/- months post final treatment
Incidence of intracranial hemorrhage during follow-up.
Incidence of intracranial hemorrhage during follow-up.
Time frame: Within 3 +/- months post final treatment
Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
Time frame: at 3(+/-1) months post-treatment.
Plan to share: No
Ran from Aug 2018 to primary completion in Jan 2025, 77 months.
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