A Randomized Trial of Unruptured Brain AVMs (ARUBA)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unruptured Brain Arteriovenous Malformation |
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Unruptured Brain Arteriovenous Malformations |
- Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging) [ Time Frame: from enrollment to study end for primary outcomes of death or symptomatic stroke including hemorrhage ] [ Designated as safety issue: Yes ]
- Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization [ Time Frame: from enrollment to study end for primary outcomes of death or symptomatic stroke including hemorrhage ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Symptomatic medical management alone: 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. |
|
|
Active Comparator: 2
Symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy): 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. |
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination]
All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. Endovascular procedures involve specially designed catheters/tubes position in the small arteries feeding blood to the AVM. The tubes are inserted into an artery in the groin and threaded up through the artery into the brain. Once positioned, the physician injects a special material that changes from liquid to solid very quickly. Once it solidifies, it blocks the artery that is feeding blood to the AVM. Neurosurgery involves the opening of a portion of the skull and the brain's outer lining to get access to the AVM. Radiosurgery involves high energy radiation (like X-rays) carefully targeted at the brain AVM to shrink it and, in the best results, eventually eliminate the artery-to-vein links and the risk of bleeding. The effect often takes one to two years to occur. |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must have unruptured BAVM diagnosed by MRI/MRA and/or angiogram
- Patient must be 18 years of age or older
Exclusion Criteria:
- Patient has evidence of recent or prior BAVM hemorrhage
- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Patient has BAVM deemed untreatable by local investigator, or has concomitant vascular or brain disease that interferes with/or contradicts any invasive therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- Patient has baseline Rankin ≥2
- Patient has concomitant disease reducing life expectancy to less than 10 years
- Patient has thrombocytopenia (< 100,000/nl) or coagulopathy (spontaneous or iatrogenic INR>1.5)
- Patient is pregnant or lactating
- Patient has known allergy against iodine contrast agents, multiple-foci BAVMs, or any form of arteriovenous or spinal fistulas
- Patient has a diagnosed Vein of Galen type malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- Patient has diagnosed BAVMs in context of moya-moya-type changes, or hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00389181
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| United States, Arizona | |
| Barrow Neurological Institute, 350 West Thomas Road | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd | |
| Los Angeles, California, United States, 90027 | |
| University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza | |
| Los Angeles, California, United States, 90095-1769 | |
| Kaiser Permanente (SF) | |
| Redwood City, California, United States, 94063 | |
| University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38 | |
| San Francisco, California, United States, 94110 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33146 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700 | |
| Maywood, Illinois, United States, 60153-3304 | |
| United States, Iowa | |
| University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive , | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Michigan | |
| Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road | |
| Southfield, Michigan, United States, 48075 | |
| United States, New Jersey | |
| St. Joseph's Regional Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| United States, New York | |
| SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189 | |
| Brooklyn, New York, United States, 11203-2098 | |
| Mercy Hospital of Buffalo | |
| Buffalo, New York, United States, 14220 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136 | |
| New York, New York, United States, 10029 | |
| New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120, | |
| Johnstown,, Pennsylvania, United States, 15904 | |
| Thomas Jefferson Hospital for Neuroscience | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street | |
| Austin, Texas, United States, 78701 | |
| University of Texas Medical School in Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212 | |
| Charlottesville, Virginia, United States, 22908 | |
| Sentara Medical Group | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Wisconsin | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-4874 | |
| Australia, Queensland | |
| Wesley Medical Center | |
| Auchenflower, Queensland, Australia, 4066 | |
| Australia, Victoria | |
| Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights | |
| Melbourne, Victoria, Australia, 3081 | |
| Austria | |
| Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck | |
| Innsbruck, Austria | |
| Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030 | |
| Wien, Austria | |
| Brazil | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Brazil | |
| Canada, Ontario | |
| Hamilton General Hospital .237 Barton Street East | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| London Health Sciences Center | |
| London, Ontario, Canada, N6A 5W9 | |
| Canada, Quebec | |
| CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Finland | |
| Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266 | |
| Helsinki, Finland, FI-00029 HUS | |
| France | |
| Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent | |
| Brest cedex, France, 29609 | |
| CHU Henri Mondor, Service de Neuroradiologie | |
| Creteil Cedex, France, 94010 | |
| Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU | |
| Lille Cedex, France, 59037 | |
| European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10, | |
| Paris, France | |
| Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis | |
| Paris, France, 75014 | |
| Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré | |
| Paris cedex 10, France, 75475 | |
| Germany | |
| Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30 | |
| Berlin, Germany, 12200 | |
| Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74 | |
| Dresden, Germany, 01307 | |
| Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55 | |
| Essen, Germany, 45147 | |
| Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16 | |
| Frankfurt am Main, Germany, 60528 | |
| Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64 | |
| Freiburg, Germany, 79106 | |
| Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165 | |
| Halle, Germany, 06112 | |
| Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52 | |
| Hamburg, Germany, 20246 | |
| Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400 | |
| Heidelberg, Germany, 69120 | |
| Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15 | |
| Munich, Germany, 81377 | |
| Italy | |
| Bellaria Hospital, Department of Neurosurgery | |
| Bologna, Italy, 40139 | |
| Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60 | |
| Milano, Italy, 20131 | |
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 1 10-744 | |
| Netherlands | |
| Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1 | |
| Groningen, Netherlands, 9700 | |
| Utrecht University Hospital, Heidelberglaan 100, 3584 CX | |
| Utrecht, Netherlands | |
| Spain | |
| Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat | |
| Barcelona, Spain, 08907 | |
| Switzerland | |
| Inselspital, Neurologische Klinik, 3010 Bern | |
| Schweiz, Switzerland | |
| United Kingdom | |
| Frenchay Hospital, Neuroradiology Department | |
| Bristol, United Kingdom, BS 16 1LE | |
| Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street | |
| Leeds, United Kingdom, LS1 3EX | |
| Walton Centre for Neurology, Lower Lane Fazakerley | |
| Liverpool, United Kingdom, L9 7LJ | |
| Institute of Neurology, Box 6, The National Hospital, Queen Square | |
| London, United Kingdom, WC12N 3BG | |
| Department of Neurosurgery, Newcastle General Hospital, Westgate Road | |
| Newcastle upon Tyne, United Kingdom, NE4 6BE | |
| Imaging Directorate, Derriford Hospital | |
| Plymouth, United Kingdom, PL6 8DH | |
| Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood | |
| Preston, United Kingdom, PR2 9HP | |
| Department of Neurology, Hope Hospital | |
| Salford, United Kingdom, M6 8HD | |
| Department of Neurology, Royal Hallamshire Hospital, Glossop Road | |
| Sheffield, United Kingdom, 810 2JF | |
| Principal Investigator: | J.P. Mohr, MS, MD | Stroke Center/The Neurological Institute, Columbia University | |
| Principal Investigator: | Alan J. Moskowitz, MD | InCHOIR, Department of Health Policy, Mount Sinai School of Medicine | |
| Principal Investigator: | Michael Parides, PhD | InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI | |
| Principal Investigator: | Christian Stapf, MD | Clinical Coordinating Center, Europe | |
| Principal Investigator: | Eric Vicaut, MD | Clinical Coordinating Center, Europe, Co-PI | |
| Principal Investigator: | Claudia S. Moy, PhD | NINDS, Co-PI |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jay Preston Mohr, Daniel Sciarra Professor of Neurology, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00389181 History of Changes |
| Other Study ID Numbers: | AAAB6286, U01NS051566, U01NS051483 |
| Study First Received: | October 16, 2006 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Columbia University:
|
unruptured brain arteriovenous malformation AVM BAVM Stroke Intracranial Hemorrhage |
Additional relevant MeSH terms:
|
Arteriovenous Malformations Congenital Abnormalities Hemangioma Cardiovascular Abnormalities Cardiovascular Diseases |
Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Vascular Diseases Vascular Malformations |
ClinicalTrials.gov processed this record on February 27, 2015