Clinical trial NCT03691870: Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations
Official title: Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arteriovenous Malformations, Cerebral
Unruptured Brain Arteriovenous Malformation
Ruptured Brain Arteriovenous Malformation
Keywords: brain arteriovenous malformation
Arteriovenous malformations
AVM
BAVM
stroke
intracranial hemorrhage
congenital abnormalities
aneurysm
vascular malformations
cardiovascular abnormalities
cardiovascular diseases
vascular diseases
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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:

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.

Exclusion Criteria:

* Absolute contra-indication to endovascular treatment or anesthesia.
* Inability to obtain informed consent.

Primary outcomes:
measure: Angiographic evidence of residual AVM at time of confirmatory catheter angiography.
timeFrame: 3 months +/- 1 month following embolization
Secondary outcomes:
measure: Failure to safely and effectively position the embolization microcatheter.
timeFrame: within day of procedure
measure: Any procedural complication leading to transient new neurological deficit.
timeFrame: <5 days
measure: Any procedural complication leading to new neurological deficit.
timeFrame: ≥5 days
measure: Any treatment-related complication that prolongs hospitalization by ≥5 days.
timeFrame: Within one week
measure: Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
timeFrame: within 5 days post procedure
measure: Length of hospitalization (days).
timeFrame: ≥5 days
measure: Patient discharge to a location that is not his/her home.
timeFrame: through to 3 (+/- 1) months follow-up
measure: mRS at discharge and 3(+/-1) months.
timeFrame: through to 3 (+/- 1) months follow-up
measure: Incidence of new admission to hospital during follow-up.
timeFrame: Within 3 +/- months post final treatment
measure: Incidence of intracranial hemorrhage during follow-up.
timeFrame: Within 3 +/- months post final treatment
measure: Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
timeFrame: at 3(+/-1) months post-treatment.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Bordeaux
country: France
facility: Centre hospitalier universitaire de Bordeaux
city: Brest
country: France
facility: Centre hospitalier régional universitaire de Brest
city: Grenoble
country: France
facility: Centre hospitalier universitaire de Grenoble
city: Limoges
country: France
facility: Centre hospitalier universitaire Limoges
city: Paris
country: France
facility: Hôpital Forndation Adolphe de Rothschild
city: Rouen
country: France
facility: Centre hospitalier universitaire de Rouen Normandie
city: Saint-Paul
country: France
facility: Centre hospitalier universitaire de la Réunion
Study officials:
References:
citation: van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632.
citation: Iosif C, Mendes GA, Saleme S, Ponomarjova S, Silveira EP, Caire F, Mounayer C. Endovascular transvenous cure for ruptured brain arteriovenous malformations in complex cases with high Spetzler-Martin grades. J Neurosurg. 2015 May;122(5):1229-38. doi: 10.3171/2014.9.JNS141714. Epub 2015 Mar 20.
citation: Kessler I, Riva R, Ruggiero M, Manisor M, Al-Khawaldeh M, Mounayer C. Successful transvenous embolization of brain arteriovenous malformations using Onyx in five consecutive patients. Neurosurgery. 2011 Jul;69(1):184-93; discussion 193. doi: 10.1227/NEU.0b013e318212bb34.
citation: Mendes GAC, Kalani MYS, Iosif C, Lucena AF, Carvalho R, Saleme S, Mounayer C. Transvenous Curative Embolization of Cerebral Arteriovenous Malformations: A Prospective Cohort Study. Neurosurgery. 2018 Nov 1;83(5):957-964. doi: 10.1093/neuros/nyx581.
citation: Zhang G, Zhu S, Wu P, Xu S, Shi H. The transvenous pressure cooker technique: A treatment for brain arteriovenous malformations. Interv Neuroradiol. 2017 Apr;23(2):194-199. doi: 10.1177/1591019916682357. Epub 2016 Dec 5.
citation: Raymond J, Darsaut TE, Altman DG. Pragmatic trials can be designed as optimal medical care: principles and methods of care trials. J Clin Epidemiol. 2014 Oct;67(10):1150-6. doi: 10.1016/j.jclinepi.2014.04.010. Epub 2014 Jul 16.
citation: Raymond J, Fahed R, Darsaut TE. Randomize the first patient. J Neuroradiol. 2017 Sep;44(5):291-294. doi: 10.1016/j.neurad.2017.03.004. Epub 2017 May 3. No abstract available.
citation: Fahed R, Darsaut TE, Mounayer C, Chapot R, Piotin M, Blanc R, Mendes Pereira V, Abud DG, Iancu D, Weill A, Roy D, Nico L, Nolet S, Gevry G, Raymond J. Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial. Interv Neuroradiol. 2019 Jun;25(3):305-309. doi: 10.1177/1591019918821738. Epub 2019 Feb 4.