Brief Summary
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.
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.
Brief Title
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Arteriovenous Malformations, Cerebral
Unruptured Brain Arteriovenous Malformation
Ruptured Brain Arteriovenous Malformation
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
brain arteriovenous malformation
Arteriovenous malformations
AVM
BAVM
stroke
intracranial hemorrhage
congenital abnormalities
aneurysm
vascular malformations
cardiovascular abnormalities
cardiovascular diseases
vascular diseases
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT03691870
Org Class
Other
Org Full Name
Centre hospitalier de l'Université de Montréal (CHUM)
Org Study Id
18.118
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry
Primary Outcomes
Outcome Description
Angiographic evidence of residual AVM at time of confirmatory catheter angiography
Outcome Measure
Angiographic evidence of residual AVM at time of confirmatory catheter angiography.
Outcome Time Frame
3 months +/- 1 month following embolization
Secondary Outcomes
Outcome Description
Failure to reach a safe and effective microcatheter position for embolization.
Outcome Time Frame
within day of procedure
Outcome Measure
Failure to safely and effectively position the embolization microcatheter.
Outcome Description
Any procedural complication leading to transient new neurological deficit.
Outcome Time Frame
<5 days
Outcome Measure
Any procedural complication leading to transient new neurological deficit.
Outcome Description
Any procedural complication leading to new neurological deficit.
Outcome Time Frame
≥5 days
Outcome Measure
Any procedural complication leading to new neurological deficit.
Outcome Description
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Outcome Time Frame
Within one week
Outcome Measure
Any treatment-related complication that prolongs hospitalization by ≥5 days.
Outcome Description
Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
Outcome Time Frame
within 5 days post procedure
Outcome Measure
Incidence of new ischemia following treatment (Brain MR imaging prior to discharge with diffusion sequences).
Outcome Description
Length of hospitalization (days).
Outcome Time Frame
≥5 days
Outcome Measure
Length of hospitalization (days).
Outcome Description
Discharge to location other than home.
Outcome Time Frame
through to 3 (+/- 1) months follow-up
Outcome Measure
Patient discharge to a location that is not his/her home.
Outcome Description
mRS at discharge and 3(+/-1) months.
Outcome Time Frame
through to 3 (+/- 1) months follow-up
Outcome Measure
mRS at discharge and 3(+/-1) months.
Outcome Description
Incidence of new admission to hospital during follow-up.
Outcome Time Frame
Within 3 +/- months post final treatment
Outcome Measure
Incidence of new admission to hospital during follow-up.
Outcome Description
Incidence of intracranial hemorrhage during follow-up.
Outcome Time Frame
Within 3 +/- months post final treatment
Outcome Measure
Incidence of intracranial hemorrhage during follow-up.
Outcome Description
Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
Outcome Time Frame
at 3(+/-1) months post-treatment.
Outcome Measure
Incidence of residual AVM on confirmatory catheter angiography at 3(+/-1) months post-treatment.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498