Informations générales (source: ClinicalTrials.gov)
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry (TATAM)
Interventional
N/A
Centre hospitalier de l'Université de Montréal (CHUM) (Voir sur ClinicalTrials)
août 2018
décembre 2025
24 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Michel PIOTIN | 21/06/2024 13:33:26 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier régional universitaire de Brest - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire de Bordeaux - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire de Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire de la Réunion - Saint-Paul - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire de Rouen Normandie - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier universitaire Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hôpital Forndation Adolphe de Rothschild - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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:
1. 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.
2. 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.
- 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:
1. 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.
2. 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.
- Absolute contra-indication to endovascular treatment or anesthesia.
- Inability to obtain informed consent.