Transvenous Embolization for Brain AVM

(TATAM Trial)

Recruiting at 8 trial locations

Overseen By Tim Darsaut, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Endovascular treatment, Anesthesia, Informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Transvenous Embolization (TVE) for Brain AVM?

Research shows that Transvenous Embolization (TVE) is a promising treatment for brain arteriovenous malformations (AVMs), especially in cases where the AVM is small, has bled, or is difficult to reach through arteries. Studies have found that TVE can be safe and effective, sometimes offering a better chance of completely closing off the AVM compared to the standard Trans-Arterial Embolization (TAE). ^{1 2 3 4 5}

Is transvenous embolization (TVE) generally safe for treating brain arteriovenous malformations (AVMs)?

Transvenous embolization (TVE) has been shown to be a safe and feasible treatment option for brain arteriovenous malformations (AVMs) in several studies. It is considered a promising alternative to traditional methods, especially for certain types of AVMs. ^{1 2 3 4 5}

How is transvenous embolization (TVE) different from other treatments for brain arteriovenous malformations (AVMs)?

Transvenous embolization (TVE) is a novel treatment for brain arteriovenous malformations (AVMs) that involves accessing the blood vessels through veins rather than arteries, which is different from the standard trans-arterial embolization (TAE). This approach can be particularly useful for AVMs that are difficult to treat with traditional methods, offering a potentially safer and more effective option in certain cases. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for patients with brain AVMs, either ruptured or unruptured. Candidates should be stable and past the acute phase of rupture if applicable. The treatment looks promising for small AVMs with a single draining vein that can potentially be cured in one or two sessions. Cases must get approval from the Case Selection Committee.

Inclusion Criteria

Case must be approved by the CSC.

My condition is stable after an AVM rupture, if it happened.

My AVM has been treated before, but I can still consider this trial.

Exclusion Criteria

I cannot undergo treatments involving catheters or anesthesia due to health risks.

Inability to obtain informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Trans-Venous Embolization (TVE) or standard Trans-Arterial Embolization (TAE) to treat cerebral arteriovenous malformations

1-2 weeks

Multiple sessions as needed

Follow-up

Participants are monitored for angiographic evidence of residual AVM and other complications

3 months

Regular follow-up visits

Treatment Details

Interventions

• Standard Trans-Arterial Embolization (TAE)
• Trans-Venous Embolization (TVE)

Trial Overview The study tests Trans-Venous Embolization (TVE) against Standard Trans-Arterial Embolization (TAE) for treating brain AVMs. TVE involves using microcatheters to fill the lesion retrogradely, which may improve occlusion rates compared to arterial approaches.

Participant Groups

Group I: Trans-Venous Embolization (TVE) (+/- Arterial) strategy Experimental Treatment 1 Intervention

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 II: standard Trans-Arterial Embolization (TAE) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transvenous embolization of hemorrhagic brain arteriovenous malformations: Case reports and literature review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Experimental investigation of transvenous embolization of arteriovenous malformations using different in vivo models. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Endovascular transvenous treatment for superficial intracranial arteriovenous malformations. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Worldwide Research Trends on Transvenous Embolization of Brain Arteriovenous Malformations: A Bibliometric and Visualized Study. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

[Arteriovenous Malformations:Endovascular Techniques and Devices]. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

Transarterial and Transvenous Coil Embolization of Direct Carotid-Cavernous Fistulas. [2023]