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Treatment of Brain AVMs (TOBAS) Study
NCT02098252 · View on ClinicalTrials.gov ↗
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%.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02098252
The ClinicalTrials.gov registry entry for NCT02098252 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02098252 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02098252?
The interventions under investigation include: Radiation therapy (RADIATION), Embolization (PROCEDURE), Neurosurgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02098252?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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