Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM)
Arteriovenous Malformations, Cerebral, Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation
About this trial
This is an interventional treatment trial for Arteriovenous Malformations, Cerebral focused on measuring brain arteriovenous malformation, Arteriovenous malformations, AVM, BAVM, stroke, intracranial hemorrhage, congenital abnormalities, aneurysm, vascular malformations, cardiovascular abnormalities, cardiovascular diseases, vascular diseases
Eligibility Criteria
Inclusion Criteria:
- Any patient harboring a brain AVM (ruptured or unruptured) in whom TVE is considered a promising but yet unproven therapeutic option by the participating clinicians can be submitted to the Case Selection Committee.
- Patients must be in stable, non-urgent clinical condition, with the acute phase of the AVM rupture resolved (where applicable).
- Case must be approved by the CSC.
Notes on potentially suitable cases:
- Current indications may include (but are NOT restricted to) brain AVMs with a small <3 cm nidus (or small residual nidus), with a single draining vein, and for which curative treatment can be attained with one or at most two treatment sessions.
- Physicians are not required to submit cases prior to any or all treatment; a case can be submitted to the CSC for consideration after previous treatments (including previous arterial embolization sessions) have been performed. The timing of the submission of the case will be left to individual operators. Previously treated AVMs (by any other modality: embolization/surgical resection/radiosurgery) are not excluded from TATAM.
Exclusion Criteria:
- Absolute contra-indication to endovascular treatment or anesthesia.
- Inability to obtain informed consent.
Sites / Locations
- University of Alberta HospitalRecruiting
- Centre Hospitalier de l'Université de MontréalRecruiting
- Centre hospitalier universitaire de Bordeaux
- Centre hospitalier régional universitaire de BrestRecruiting
- Centre hospitalier universitaire de GrenobleRecruiting
- Centre hospitalier universitaire LimogesRecruiting
- Hôpital Forndation Adolphe de RothschildRecruiting
- Centre hospitalier universitaire de Rouen NormandieRecruiting
- Centre hospitalier universitaire de la RéunionRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
standard Trans-Arterial Embolization (TAE)
Trans-Venous Embolization (TVE) (+/- Arterial) strategy
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.
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).