Transvenous Embolization for Brain AVM

(TATAM Trial)

No longer recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating brain arteriovenous malformations (AVMs), which are tangled blood vessels in the brain that can cause serious problems. The study compares two methods: the standard treatment, Standard Trans-Arterial Embolization (TAE), where doctors block the AVM through arteries, and a newer method, Trans-Venous Embolization (TVE), which involves blocking it through veins and might be more effective in certain cases. Individuals with a brain AVM that is either small or has a single draining vein, and who are in stable condition, might be suitable candidates for this trial. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this technique is safe for treating brain AVMs?

Research has shown that Trans-Venous Embolization (TVE) is generally safe for treating brain arteriovenous malformations (AVMs). In one study, the risk of serious complications or death was about 4.8% out of 21 cases. Another review found that TVE has a low death rate and often successfully blocks the AVM, which is encouraging.

While TVE has proven more effective in imaging results compared to the standard Trans-Arterial Embolization (TAE), both treatments carry similar high risks. This suggests that TVE might work better in some cases, but side effects remain possible.

Overall, TVE appears to be a promising option, but it remains experimental. Therefore, discussing the benefits and risks with a healthcare provider is crucial before deciding to participate in such a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trans-Venous Embolization (TVE) strategy because it offers a new way to tackle brain arteriovenous malformations (AVMs). Unlike the standard Trans-Arterial Embolization (TAE) that approaches the AVM through the arteries, TVE uses venous catheterization and retrograde injection of ethyl vinyl alcohol (EVOH) to potentially achieve complete occlusion. This innovative approach could offer a safer and more effective treatment by allowing flexibility in combining both arterial and venous routes as needed, potentially reducing the risks associated with traditional arterial methods.

What evidence suggests that the Trans-Venous Embolization (TVE) technique is effective for treating brain AVMs?

Research has shown that Trans-Venous Embolization (TVE), one of the treatments studied in this trial, could be a promising option for brain arteriovenous malformations (AVMs). Studies found that TVE successfully blocked the AVM in 96% to 100% of cases, with patients generally recovering well after the procedure. The risk of complications was relatively low, between 4.3% and 4.8%, and no deaths related to the treatment were reported. This suggests that TVE might be an effective and relatively safe option for people with brain AVMs. Meanwhile, the trial will also evaluate the standard Trans-Arterial Embolization (TAE) as a comparator treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.049109?doi=10.1161/STROKEAHA.124.049109

Transvenous Approach for the Treatment of Cerebral ... TVE was more effective than TAE in terms of angiographic results at 3 to 6 months. Morbidity was similar but high for both groups.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417439/

Transvenous curative embolization of brain arteriovenous ... Complete angiographic occlusion was achieved in all patients (100%), with mRS scores indicating favorable outcomes at discharge and follow-up.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7028574/

Safety and Efficacy of Transvenous Embolization ... Both the morbidity and mortality rates were 4.8% (1/21). CONCLUSIONS: Transvenous embolization can be performed only in highly selected hemorrhagic brain AVMs ...

4. thejns.org thejns.org/focus/view/journals/neurosurg-focus/45/1/article-pE13.xml

Transvenous embolization of brain arteriovenous malformations Complete AVM obliteration was achieved in 93% of cases for which the intent of treatment was curative embolization. The complication rate was modest (4.3%).

5. mayoclinic.elsevierpure.com mayoclinic.elsevierpure.com/en/publications/transvenous-embolization-of-brain-arteriovenous-malformations-a-s

Transvenous embolization of brain arteriovenous ... There were no cases of treatment related mortality. Overall good functional outcome rates were 89.0% (95% CI: 82.0-96.0%). Complete occlusion rates were 96.0% ( ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37787162/

A systematic review and meta-analysis Transvenous embolization for brain arteriovenous malformation shows promising safety and effectiveness, with low mortality, a considerable rate of positive ...

7. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001689

Transvenous Embolization of a Brainstem Arteriovenous ... Ruptured brainstem AVMs carry a higher risk of rebleeding and mortality. Various treatments including microsurgical resection, radiosurgery, and ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/15910199231204922?int.sj-full-text.similar-articles.6

A systematic review and meta-analysis Our results show that TVE is a safe and effective treatment option, with a low all-cause mortality rate and a high rate of bAVM complete ...