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Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM)

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Standard Trans-Arterial Embolization (TAE)

Trans-Venous Embolization (TVE)

About this trial

This is an interventional treatment trial for Arteriovenous Malformations, Cerebral focused on measuring brain arteriovenous malformation, Arteriovenous malformations, AVM, BAVM, stroke, intracranial hemorrhage, congenital abnormalities, aneurysm, vascular malformations, cardiovascular abnormalities, cardiovascular diseases, vascular diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Exclusion Criteria:

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

Sites / Locations

University of Alberta HospitalRecruiting
Centre Hospitalier de l'Université de MontréalRecruiting
Centre hospitalier universitaire de Bordeaux
Centre hospitalier régional universitaire de BrestRecruiting
Centre hospitalier universitaire de GrenobleRecruiting
Centre hospitalier universitaire LimogesRecruiting
Hôpital Forndation Adolphe de RothschildRecruiting
Centre hospitalier universitaire de Rouen NormandieRecruiting
Centre hospitalier universitaire de la RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard Trans-Arterial Embolization (TAE)

Trans-Venous Embolization (TVE) (+/- Arterial) strategy

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Angiographic evidence of residual AVM at time of confirmatory catheter angiography

Secondary Outcome Measures

Failure to safely and effectively position the embolization microcatheter.

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

Any procedural complication leading to transient new neurological deficit.

Any procedural complication leading to new neurological deficit.

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

Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).

Length of hospitalization (days).

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

Discharge to location other than home.

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

Incidence of new admission to hospital during follow-up.

Incidence of intracranial hemorrhage during follow-up.

Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.

Full Information

NCT ID

NCT03691870

First Posted

September 20, 2018

Last Updated

July 4, 2023

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT03691870

Brief Title

Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

Acronym

TATAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2, 2018 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard Trans-Arterial Embolization (TAE)

Arm Type

Active Comparator

Arm Description

Arm Title

Trans-Venous Embolization (TVE) (+/- Arterial) strategy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Standard Trans-Arterial Embolization (TAE)

Intervention Description

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

Intervention Name(s)

Trans-Venous Embolization (TVE)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Angiographic evidence of residual AVM at time of confirmatory catheter angiography

Time Frame

3 months +/- 1 month following embolization

Secondary Outcome Measure Information:

Title

Failure to safely and effectively position the embolization microcatheter.

Description

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

Time Frame

within day of procedure

Title

Any procedural complication leading to transient new neurological deficit.

Description

Any procedural complication leading to transient new neurological deficit.

Time Frame

<5 days

Title

Any procedural complication leading to new neurological deficit.

Description

Any procedural complication leading to new neurological deficit.

Time Frame

≥5 days

Title

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

Description

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

Time Frame

Within one week

Title

Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).

Description

Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).

Time Frame

within 5 days post procedure

Title

Length of hospitalization (days).

Description

Length of hospitalization (days).

Time Frame

≥5 days

Title

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

Description

Discharge to location other than home.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Incidence of new admission to hospital during follow-up.

Description

Incidence of new admission to hospital during follow-up.

Time Frame

Within 3 +/- months post final treatment

Title

Incidence of intracranial hemorrhage during follow-up.

Description

Incidence of intracranial hemorrhage during follow-up.

Time Frame

Within 3 +/- months post final treatment

Title

Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.

Description

Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Raymond, MD

Phone

514-890-8000

Ext

27235

jraymond.nri@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tim Darsaut, MD

Phone

780-407-1440

tdarsaut@ualberta.ca

Facility Information:

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tim Darsaut, MD

tdarsaut@ualberta.ca

First Name & Middle Initial & Last Name & Degree

Tim Darsaut, MD

Facility Name

Centre Hospitalier de l'Université de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0C1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guylaine Gevry

Phone

514-890-8000

Ext

27235

guylaine.gevry.chum@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Ruby Klink, PhD

Phone

514-890-8000

Ext

26359

Ruby.Klink@crchum.qc.ca

First Name & Middle Initial & Last Name & Degree

Jean Raymond, MD

First Name & Middle Initial & Last Name & Degree

Daniel Roy, MD

First Name & Middle Initial & Last Name & Degree

Alain Weill, MD

Facility Name

Centre hospitalier universitaire de Bordeaux

City

Bordeaux

Country

France

Individual Site Status

Active, not recruiting

Facility Name

Centre hospitalier régional universitaire de Brest

City

Brest

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Gentric, MD

jean-christophe.gentric@chu-brest.fr

First Name & Middle Initial & Last Name & Degree

Jean-Christophe Gentric, MD

Facility Name

Centre hospitalier universitaire de Grenoble

City

Grenoble

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kamel Boubagra, MD

KBoubagra@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Kamel Boubagra, MD

First Name & Middle Initial & Last Name & Degree

Olivier Heck, MD

Facility Name

Centre hospitalier universitaire Limoges

City

Limoges

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emanuelle Lorian

emmanuelle.lorian@chu-limoges.fr

First Name & Middle Initial & Last Name & Degree

Charbel Mounayer, MD

Facility Name

Hôpital Forndation Adolphe de Rothschild

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michel Piotin, MD

mpiotin@for.paris

First Name & Middle Initial & Last Name & Degree

Michel Piotin, MD

Facility Name

Centre hospitalier universitaire de Rouen Normandie

City

Rouen

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chrysanthi Papagiannaki, MD

C.Papagiannaki@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Chrysanthi Papagiannaki, MD

Facility Name

Centre hospitalier universitaire de la Réunion

City

Saint-Paul

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Bintner, MD

Phone

02 62 35 90 86

marc.bintner@chu-reunion.fr

First Name & Middle Initial & Last Name & Degree

Marc Bintner, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22068993

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.

Results Reference

background

PubMed Identifier

25794338

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.

Results Reference

background

PubMed Identifier

21346657

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.

Results Reference

background

PubMed Identifier

29281075

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.

Results Reference

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PubMed Identifier

27913800

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.

Results Reference

background

PubMed Identifier

25042688

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.

Results Reference

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PubMed Identifier

28478113

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.

Results Reference

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PubMed Identifier

30843441

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.

Results Reference

derived

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Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

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