Condition: Unruptured Brain Arteriovenous Malformation · Ruptured Brain Arteriovenous Malformation · Arteriovenous Malformations · Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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%.
This description comes directly from the study's public registry record.
Daniel Roy, MD · 514-890-8000 · daniel.roy.chum@ssss.gouv.qc.ca
Tim Darsaut, MD · 780-407-1440 · tdarsaut@ualberta.ca
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| Mayo Clinic in Jacksonville FL | Jacksonville, Florida, United States | Recruiting |
| Boston Medical Center | Boston, Massachusetts, United States | Recruiting |
| University of New Mexico Health Sciences Center | Albuquerque, New Mexico, United States | Recruiting |
| Hospital Geral de Fortaleza | Fortaleza, Brazil | Recruiting |
| Universidade Federal de Sǎo Paulo | São Paulo, Brazil | Recruiting |
| University of Alberta Hospital | Edmonton, Alberta, Canada | Recruiting |
| Klink, Ruby | Montreal, Quebec, Canada | Recruiting |
| Instituto de Neurocirugia Dr. A. Asenjo | Santiago, Chile | Recruiting |
| Universidad Autonoma de Bucaramanga | Bucaramanga, Colombia | Recruiting |
| CHRU de Brest (Brest University Hospital) | Brest, Brittany Region, France | Recruiting |
| Centre Hospit Régional Universitaire de Besançon | Besançon, France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux, France | Recruiting |
+ 18 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02098252