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

March 15, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • Quebec
      • Montréal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Université de Montréal
  • France
      • Bordeaux, France
        • Centre Hospitalier Universitaire de Bordeaux
      • Brest, France
        • Centre hospitalier régional universitaire de Brest
      • Grenoble, France
        • Centre Hospitalier Universitaire de Grenoble
      • Limoges, France
        • Centre Hospitalier Universitaire Limoges
      • Paris, France
        • Hôpital Forndation Adolphe de Rothschild
      • Rouen, France
        • Centre hospitalier universitaire de Rouen Normandie
      • Saint-Paul, France
        • Centre hospitalier universitaire de la Réunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months +/- 1 month following embolization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unruptured Brain Arteriovenous Malformation

Clinical Trials on Standard Trans-Arterial Embolization (TAE)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe