Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

NCT ID: NCT03691870

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2025-07-23

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.

Conditions

Arteriovenous Malformations, Cerebral; Unruptured Brain Arteriovenous Malformation; Ruptured Brain Arteriovenous Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Trans-Arterial Embolization (TAE)

Intervention Type: PROCEDURE

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) (+/- Arterial) strategy

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).

Group Type: EXPERIMENTAL

Trans-Venous Embolization (TVE)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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, , France

Countries

Canada; France

References

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Reference Type: BACKGROUND

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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.

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 28478113 (View on PubMed)

Raymond J, Darsaut TE, Saleme S, Rouchaud A, Iancu D, Roy D, Weill A, Olijnyk L, Jabre R, Bojanowski MW, Chaalala C, Roberge D, Boubagra K, Heck O, Rempel JL, Papagiannaki C, Barreau X, Marnat G, Gentric JC, Ognard J, Nico L, Bintner M, Gauthier Lasalarie P, Veyrieres JB, Piotin M, Escalard S, Pereira VM, Abud DG, Zehr J, Chagnon M, Nguyen TN, Mathieu D, Gevry G, Klink R, Lorian E, Mounayer C; TATAM Collaborative Group. Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations: A Randomized Comparison With Transarterial Embolization. Stroke. 2025 Jun;56(6):1396-1403. doi: 10.1161/STROKEAHA.124.049109. Epub 2025 Mar 27.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 30843441 (View on PubMed)

Other Identifiers

18.118

Identifier Type: -

Identifier Source: org_study_id