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Arteriovenous Malformations, CerebralTATAMNCT03691870

Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

A study testing Standard Trans-Arterial Embolization (TAE) and Trans-Venous Embolization (TVE) in people with Arteriovenous Malformations, Cerebral and Unruptured Brain Arteriovenous Malformation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Standard Trans-Arterial Embolization (TAE) and Trans-Venous Embolization (TVE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
9 sitesin 2 countries
Study dates
2 Aug 2018to 23 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

France7 sites
  • Centre hospitalier universitaire de Bordeaux

    Bordeaux

  • Centre hospitalier régional universitaire de Brest

    Brest

  • Centre hospitalier universitaire de Grenoble

    Grenoble

  • Centre hospitalier universitaire Limoges

    Limoges

  • Hôpital Forndation Adolphe de Rothschild

    Paris

  • Centre hospitalier universitaire de Rouen Normandie

    Rouen

  • Centre hospitalier universitaire de la Réunion

    Saint-Paul

Other trials in France

Canada2 sites
  • University of Alberta Hospital

    Edmonton, Alberta

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

Other trials in Canada

About this study

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

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.

Being tested
Standard Trans-Arterial Embolization (TAE), Trans-Venous Embolization (TVE)
Keywords
brain arteriovenous malformation, Arteriovenous malformations, AVM, BAVM, stroke, intracranial hemorrhage, congenital abnormalities, aneurysm, vascular malformations, cardiovascular abnormalities, cardiovascular diseases, vascular diseases
Medical subject headings
Intracranial Arteriovenous Malformations, Arteriovenous Malformations, Stroke, Intracranial Hemorrhages, Congenital Abnormalities, Aneurysm, Vascular Malformations, Cardiovascular Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Trans-Arterial Embolization (TAE)Procedure or surgery

    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)Procedure or surgery

    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.

Study groups in NCT03691870
Study groupRoleWhat they receive
standard Trans-Arterial Embolization (TAE)Active comparatorThe 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.
Receives: Procedure: Standard Trans-Arterial Embolization (TAE)
Trans-Venous Embolization (TVE) (+/- Arterial) strategyExperimentalThe 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).
Receives: Procedure: Trans-Venous Embolization (TVE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angiographic evidence of residual AVM at time of confirmatory catheter angiography.

    Angiographic evidence of residual AVM at time of confirmatory catheter angiography

    Measured: 3 months +/- 1 month following embolization

Secondary outcomes (11)
  1. Failure to safely and effectively position the embolization microcatheter.

    Failure to reach a safe and effective microcatheter position for embolization.

    Measured: within day of procedure

  2. Any procedural complication leading to transient new neurological deficit.

    Any procedural complication leading to transient new neurological deficit.

    Measured: <5 days

  3. Any procedural complication leading to new neurological deficit.

    Any procedural complication leading to new neurological deficit.

    Measured: ≥5 days

  4. Any treatment-related complication that prolongs hospitalization by ≥5 days.

    Any treatment-related complication that prolongs hospitalization by ≥5 days.

    Measured: Within one week

  5. 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).

    Measured: within 5 days post procedure

  6. Length of hospitalization (days).

    Length of hospitalization (days).

    Measured: ≥5 days

  7. Patient discharge to a location that is not his/her home.

    Discharge to location other than home.

    Measured: through to 3 (+/- 1) months follow-up

  8. mRS at discharge and 3(+/-1) months.

    mRS at discharge and 3(+/-1) months.

    Measured: through to 3 (+/- 1) months follow-up

  9. Incidence of new admission to hospital during follow-up.

    Incidence of new admission to hospital during follow-up.

    Measured: Within 3 +/- months post final treatment

  10. Incidence of intracranial hemorrhage during follow-up.

    Incidence of intracranial hemorrhage during follow-up.

    Measured: Within 3 +/- months post final treatment

  11. 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.

    Measured: at 3(+/-1) months post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start2 Aug 2018
  3. Primary completion24 Jan 2025
  4. Study completion23 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03691870
Sponsor's protocol ID
18.118
Acronym
TATAM
Status last verified
Jul 2025
First submitted
20 Sep 2018
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22068993
  • 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.

    PubMed 25794338
  • 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.

    PubMed 21346657
  • 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.

    PubMed 29281075
  • 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.

    PubMed 27913800
  • 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.

    PubMed 25042688
  • 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.

    PubMed 28478113
  • 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.

    PubMed 40143818
  • 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.

    PubMed 30843441

Questions about this trial

What is this clinical trial studying?

A study testing Standard Trans-Arterial Embolization (TAE) and Trans-Venous Embolization (TVE) in people with Arteriovenous Malformations, Cerebral and Unruptured Brain Arteriovenous Malformation, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angiographic evidence of residual AVM at time of confirmatory catheter angiography. (time frame: 3 months +/- 1 month following embolization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03691870, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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