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

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Arteriovenous Malformations, Cerebral, Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation
What is being tested?: Standard Trans-Arterial Embolization (TAE) and Trans-Venous Embolization (TVE)
Type of treatment: Injection or infusion, Surgery or procedure
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.

Country

City, postcode or hospital

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.

Conditions: Arteriovenous Malformations, Cerebral, Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation
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 group	Role	What they receive
standard Trans-Arterial Embolization (TAE)	Active comparator	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. Receives: Procedure: Standard Trans-Arterial Embolization (TAE)
Trans-Venous Embolization (TVE) (+/- Arterial) strategy	Experimental	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). Receives: Procedure: Trans-Venous Embolization (TVE)

What is being measured

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

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)

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
Any procedural complication leading to transient new neurological deficit.
Any procedural complication leading to transient new neurological deficit.
Measured: <5 days
Any procedural complication leading to new neurological deficit.
Any procedural complication leading to new neurological deficit.
Measured: ≥5 days
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Measured: Within one week
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
Length of hospitalization (days).
Length of hospitalization (days).
Measured: ≥5 days
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
mRS at discharge and 3(+/-1) months.
mRS at discharge and 3(+/-1) months.
Measured: through to 3 (+/- 1) months follow-up
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
Incidence of intracranial hemorrhage during follow-up.
Incidence of intracranial hemorrhage during follow-up.
Measured: Within 3 +/- months post final treatment
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.

2 Aug 201823 Jul 2025

First posted2 Oct 2018
Study start2 Aug 2018
Primary completion24 Jan 2025
Study completion23 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Arteriovenous Malformations, CerebralStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Arteriovenous Malformations, Cerebral trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry
ClinicalTrials.gov ID: NCT03691870
Acronym / sponsor ID: TATAM / 18.118
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Study start: 2 Aug 2018 (actual)
Primary completion: 24 Jan 2025 (actual)
Study completion: 23 Jul 2025 (actual)
First posted: 2 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
standard Trans-Arterial Embolization (TAE)	Active comparator	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. 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.
Trans-Venous Embolization (TVE) (+/- Arterial) strategy	Experimental	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. 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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.
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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	standard Trans-Arterial Embolization (TAE)
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.	Procedure or surgery	Trans-Venous Embolization (TVE) (+/- Arterial) strategy

Primary outcome

Angiographic evidence of residual AVM at time of confirmatory catheter angiography.
Time frame: 3 months +/- 1 month following embolization
Angiographic evidence of residual AVM at time of confirmatory catheter angiography

11 secondary outcomes

Failure to safely and effectively position the embolization microcatheter.
Time frame: within day of procedure
Any procedural complication leading to transient new neurological deficit.
Time frame: <5 days
Any procedural complication leading to new neurological deficit.
Time frame: ≥5 days
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Time frame: Within one week
Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
Time frame: within 5 days post procedure
Length of hospitalization (days).
Time frame: ≥5 days
Patient discharge to a location that is not his/her home.
Time frame: through to 3 (+/- 1) months follow-up
mRS at discharge and 3(+/-1) months.
Time frame: through to 3 (+/- 1) months follow-up
Incidence of new admission to hospital during follow-up.
Time frame: Within 3 +/- months post final treatment
Incidence of intracranial hemorrhage during follow-up.
Time frame: Within 3 +/- months post final treatment
Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
Time frame: at 3(+/-1) months post-treatment.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
Background: PubMed 22068993van 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.
Background: PubMed 25794338Iosif 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.
Background: PubMed 21346657Kessler 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.
Background: PubMed 29281075Mendes 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.
Background: PubMed 27913800Zhang 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.
Background: PubMed 25042688Raymond 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.
Background: PubMed 28478113Raymond 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.
Derived from this study: PubMed 40143818Raymond 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.
Derived from this study: PubMed 30843441Fahed 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.