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NCT02098252 · ClinicalTrials.gov registry record · NA
Treatment of Brain AVMs (TOBAS) Study
A NA study of Arteriovenous Malformations and Unruptured Brain Arteriovenous Malformation, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- Recruiting
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT02098252: Recruiting NA study of Arteriovenous Malformations and Unruptured Brain Arteriovenous Malformation, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
NCT02098252 is a NA study of Arteriovenous Malformations and Unruptured Brain Arteriovenous Malformation that is actively recruiting participants, run by Centre hospitalier de l'Université de Montréal (CHUM). The registered enrollment target is 1,000 participants, below the 3,379-participant average among 3 other Arteriovenous Malformations trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02098252, a NA study of Arteriovenous Malformations and Unruptured Brain Arteriovenous Malformation, is actively recruiting participants, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
Primary Outcome
death or disabling stroke due to hemorrhage or infarction as revealed by imaging and resulting in mRS \>2.
Conditions Studied
Interventions
- RADIATION Radiation therapy
- PROCEDURE Embolization
- PROCEDURE Neurosurgery
Study Locations (20)
Other
- Hospital Geral de Fortaleza - Fortaleza
- Universidade Federal de Sǎo Paulo - São Paulo
- Instituto de Neurocirugia Dr. A. Asenjo - Santiago
- Universidad Autonoma de Bucaramanga - Bucaramanga
- Centre Hospit Régional Universitaire de Besançon - Besançon
- Centre Hospitalier Universitaire de Bordeaux - Bordeaux
- Centre Hospitalier Universitaire de Caen - Caen
- CHU Clermont-Ferrand - Clermont-Ferrand
- CHU Dijon Bourgogne - Dijon
- Hôpital Bicêtre AP-HP - Le Kremlin-Bicêtre
- CHU Limoges - Limoges
- Centre Hospitalier Universitaire de Lyon - Lyon
- Assistance Publique - Hôpitaux de Marseille - Marseille
- Centre Hospitalier Universitaire de Montpellier - Montpellier
Florida
- Mayo Clinic in Jacksonville FL - Jacksonville
Massachusetts
- Boston Medical Center - Boston
New Mexico
- University of New Mexico Health Sciences Center - Albuquerque
Alberta
- University of Alberta Hospital - Edmonton
Quebec
- Klink, Ruby - Montreal
Brittany Region
- CHRU de Brest (Brest University Hospital) - Brest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2014-05 |
| Est. Completion | 2036-01 |
| Phase | NA |
What NCT02098252 shows while recruiting
NCT02098252 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 3,379-participant average among 3 other Arteriovenous Malformations trials with a reported enrollment target (70% lower).
The record links to 5 conditions, with Arteriovenous Malformations appearing as the primary indexed condition, and to 3 interventions - of which Radiation therapy is the first listed.
NCT02098252 names 20 study sites across 7 states, led by Other, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02098252 about?
NCT02098252 is a clinical study titled "Treatment of Brain AVMs (TOBAS) Study". The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascula...
What is the current status of trial NCT02098252?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2014-05. Estimated completion is 2036-01.
What conditions does trial NCT02098252 study?
This clinical trial studies the following conditions: Arteriovenous Malformations, Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, AVM, BAVM.
What interventions are being tested in trial NCT02098252?
The interventions under investigation include: Radiation therapy (RADIATION), Embolization (PROCEDURE), Neurosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT02098252?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02098252 being conducted?
This trial has 20 study locations across Florida, Massachusetts, New Mexico, Alberta, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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