A Randomized Trial of Unruptured Brain AVMs (ARUBA)
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| ClinicalTrials.gov Identifier: NCT00389181 |
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Recruitment Status :
Completed
First Posted : October 18, 2006
Last Update Posted : June 4, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arteriovenous Malformations, Cerebral | Procedure: Interventional therapy Other: Medical management | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 226 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial of Unruptured Brain Arteriovenous Malformations |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Medical management
Patients with unruptured BAVMs will receive symptomatic medical management alone.
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Other: Medical management
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. |
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Active Comparator: Interventional therapy
Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).
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Procedure: Interventional therapy
All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. 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. Other: Medical management 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. |
- Difference of 5-year event rates between two arms [ Time Frame: 5 years ]The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.
- Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention [ Time Frame: 5 years ]The hypothesis to be tested is that early intervention decreases the risk of death or clinical impairment at 5 years post-randomization. (Rankin Score >/= 2)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- Patient must be 18 years of age or older
- Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
Exclusion Criteria:
- Patient has BAVM presenting with evidence of recent or prior hemorrhage
- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional 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/μL),
- Patient has uncorrectable coagulopathy (INR>1.5)
- Patient is pregnant or lactating
- Patient has known allergy against iodine contrast agents
- Patient has multiple-foci BAVMs
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Patient has any form of arteriovenous or spinal fistulas
Previous diagnosis of any of the following -
- Patient has a diagnosed Vein of Galen type malformation
- Patient has a diagnosed cavernous malformation
- Patient has a diagnosed dural arteriovenous fistula
- Patient has a diagnosed venous malformation
- Patient has a diagnosed 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
- Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389181
Show 66 study locations
| 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 |
Publications:
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 |
| Other Study ID Numbers: |
AAAB6286 U01NS051566 ( U.S. NIH Grant/Contract ) U01NS051483 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 18, 2006 Key Record Dates |
| Last Update Posted: | June 4, 2015 |
| Last Verified: | June 2015 |
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Unruptured brain arteriovenous malformation AVM BAVM Stroke Intracranial Hemorrhage |
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Hemangioma Intracranial Arteriovenous Malformations Arteriovenous Malformations Congenital Abnormalities Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Diseases Neoplasms, Vascular Tissue |
Neoplasms by Histologic Type Neoplasms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases |