A Randomized Trial of Unruptured Brain AVMs (ARUBA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jay Preston Mohr, Columbia University
ClinicalTrials.gov Identifier:
NCT00389181
First received: October 16, 2006
Last updated: April 22, 2013
Last verified: April 2013

October 16, 2006
April 22, 2013
October 2006
December 2013   (final data collection date for primary outcome measure)
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 ]
Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging)
Complete list of historical versions of study NCT00389181 on ClinicalTrials.gov Archive Site
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 ]
Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization
Not Provided
Not Provided
 
A Randomized Trial of Unruptured Brain AVMs
A Randomized Trial of Unruptured Brain Arteriovenous Malformations

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unruptured Brain Arteriovenous Malformation
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.

  • 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.

    Intervention: Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
July 2017
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Brazil,   Canada,   Finland,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
NCT00389181
AAAB6286, U01NS051566, U01NS051483
Yes
Jay Preston Mohr, Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
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
Columbia University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP