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Ethanol

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).

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.

Standard Trans-Arterial Embolization (TAE)

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.

Trans-Venous Embolization (TVE)

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.

Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations

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

Angiographic evidence of residual AVM at time of confirmatory catheter angiography

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).

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.

Centre hospitalier de l'Université de Montréal (CHUM)

Patients with unruptured BAVMs will receive symptomatic medical management alone.

Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).

All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.

Interventional therapy

Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.

Medical management

J.P. Mohr, MS, MD

Alan J. Moskowitz, MD

Michael Parides, PhD

Christian Stapf, MD

Eric Vicaut, MD

Claudia S. Moy, PhD

The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.

Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.

Recent data from the literature comparing initial presentation and outcome for patients with ruptured and unruptured BAVMs have raised the possibility that such elective invasive treatment for unruptured BAVMs may yield worse outcomes than managing patients symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal of this randomized controlled trial is to determine if the long-term outcomes of patients who receive medical management for symptoms (e.g., headache, seizures) associated with an unruptured BAVM are superior to those who receive medical management and invasive therapy to eradicate the BAVM.

Participants will be randomly assigned to receive either symptomatic medical management alone or such management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Functional assessment will be carried out at the time of randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1 month, and at 6 month intervals throughout the follow up period which will be a minimum of 5 years.

A Randomized Trial of Unruptured Brain AVMs

A Randomized Trial of Unruptured Brain Arteriovenous Malformations

The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.

The hypothesis to be tested is that early intervention decreases the risk of death or clinical impairment at 5 years post-randomization. (Rankin Score \>/= 2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations	NCT03691870	Arteriovenous M... Unruptured Brai... Ruptured Brain ...	Standard Trans-... Trans-Venous Em...	-	Centre hospitalier de l'Université de Montréal (CHUM)
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations	NCT03691870	Arteriovenous M... Unruptured Brai... Ruptured Brain ...	Standard Trans-... Trans-Venous Em...	-	Centre hospitalier de l'Université de Montréal (CHUM)
A Randomized Trial of Unruptured Brain AVMs	NCT00389181	Arteriovenous M...	Interventional ... Medical managem...	18 Years -	Columbia University
A Randomized Trial of Unruptured Brain AVMs	NCT00389181	Arteriovenous M...	Interventional ... Medical managem...	18 Years -	Columbia University

Spots Global Cancer Trial Database for arteriovenous malformations, cerebral