Your session is about to expire
← Back to Search
Procedure
Transvenous Embolization for Brain AVM (TATAM Trial)
N/A
Waitlist Available
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be in stable, non-urgent clinical condition, with the acute phase of the AVM rupture resolved (where applicable).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through to 3 (+/- 1) months follow-up
Awards & highlights
TATAM Trial Summary
This trial aims to provide a safe and efficient endovascular treatment for brain arteriovenous malformations (AVMs). Trans-venous embolization (TVE) is a new technique that uses microcatheters to navigate to the draining veins of AVMs and fill the AVM nidus retrogradely with liquid embolic agents. This trial will help to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, endovascular procedures like TVE could include risks such as bleeding, infection at the catheter site, allergic reaction to embolic agents, stroke-like symptoms due to changes in blood flow, or other complications related to catheter navigation.
TATAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is stable after an AVM rupture, if it happened.
TATAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3(+/-1) months post-treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3(+/-1) months post-treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Angiographic evidence of residual AVM at time of confirmatory catheter angiography.
Secondary outcome measures
Any procedural complication leading to new neurological deficit.
Any procedural complication leading to transient new neurological deficit.
Any treatment-related complication that prolongs hospitalization by ≥5 days.
+8 moreTATAM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Trans-Venous Embolization (TVE) (+/- Arterial) strategyExperimental Treatment1 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 Control1 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.
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo treatments involving catheters or anesthesia due to health risks.My condition is stable after an AVM rupture, if it happened.My AVM has been treated before, but I can still consider this trial.I have a brain AVM and my doctor thinks a new treatment could help.My brain AVM is small, has one draining vein, and can be treated in 1-2 sessions.
Research Study Groups:
This trial has the following groups:- Group 1: standard Trans-Arterial Embolization (TAE)
- Group 2: Trans-Venous Embolization (TVE) (+/- Arterial) strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this clinical study still an ongoing process?
"Indeed, as per clinicaltrials.gov, this experiment is recruiting participants right now. Originally posted on August 2nd 2018 and last updated 8th of August 2022, it seeks 76 volunteers split between two medical centres."
Answered by AI
How many participants are being administered the treatment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial was initially posted on August 2nd 2018 and is now actively recruiting. The research requires 76 participants from two different medical facilities."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger