Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

Arteriovenous Malformations, Cerebral Clinical Trial

— TATAM  

Official title:

Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03691870
• Other study ID #: 18.118
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Arteriovenous Malformations, Cerebral
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations
• Ruptured Brain Arteriovenous Malformation
• Unruptured Brain Arteriovenous Malformation

Intervention

Procedure:
• Standard Trans-Arterial Embolization (TAE)
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.
• Trans-Venous Embolization (TVE)
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.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
France	Centre hospitalier universitaire de Bordeaux	Bordeaux
France	Centre hospitalier régional universitaire de Brest	Brest
France	Centre hospitalier universitaire de Grenoble	Grenoble
France	Centre hospitalier universitaire Limoges	Limoges
France	Hôpital Forndation Adolphe de Rothschild	Paris
France	Centre hospitalier universitaire de Rouen Normandie	Rouen
France	Centre hospitalier universitaire de la Réunion	Saint-Paul

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Countries where clinical trial is conducted

Canada,  France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic evidence of residual AVM at time of confirmatory catheter angiography.	Angiographic evidence of residual AVM at time of confirmatory catheter angiography	3 months +/- 1 month following embolization
Secondary	Failure to safely and effectively position the embolization microcatheter.	Failure to reach a safe and effective microcatheter position for embolization.	within day of procedure
Secondary	Any procedural complication leading to transient new neurological deficit.	Any procedural complication leading to transient new neurological deficit.	<5 days
Secondary	Any procedural complication leading to new neurological deficit.	Any procedural complication leading to new neurological deficit.	=5 days
Secondary	Any treatment-related complication that prolongs hospitalization by =5 days.	Any treatment-related complication that prolongs hospitalization by =5 days.	Within one week
Secondary	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).	within 5 days post procedure
Secondary	Length of hospitalization (days).	Length of hospitalization (days).	=5 days
Secondary	Patient discharge to a location that is not his/her home.	Discharge to location other than home.	through to 3 (+/- 1) months follow-up
Secondary	mRS at discharge and 3(+/-1) months.	mRS at discharge and 3(+/-1) months.	through to 3 (+/- 1) months follow-up
Secondary	Incidence of new admission to hospital during follow-up.	Incidence of new admission to hospital during follow-up.	Within 3 +/- months post final treatment
Secondary	Incidence of intracranial hemorrhage during follow-up.	Incidence of intracranial hemorrhage during follow-up.	Within 3 +/- months post final treatment
Secondary	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.	at 3(+/-1) months post-treatment.