A Randomized Trial of Unruptured Brain AVMs

Phase 3

Completed

• Conditions: Arteriovenous Malformations, Cerebral

• Registration Number: NCT00389181
• Lead Sponsor: Columbia University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-18
• Primary Completion: 2013-06
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

1. Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
2. Patient must be 18 years of age or older
3. Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms

Exclusion Criteria

1. Patient has BAVM presenting with evidence of recent or prior hemorrhage

2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)

3. 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)

4. Patient has baseline Rankin ≥2

5. Patient has concomitant disease reducing life expectancy to less than 10 years

6. Patient has thrombocytopenia (< 100,000/μL),

7. Patient has uncorrectable coagulopathy (INR>1.5)

8. Patient is pregnant or lactating

9. Patient has known allergy against iodine contrast agents

10. Patient has multiple-foci BAVMs

11. Patient has any form of arteriovenous or spinal fistulas

    Previous diagnosis of any of the following -

12. Patient has a diagnosed Vein of Galen type malformation

13. Patient has a diagnosed cavernous malformation

14. Patient has a diagnosed dural arteriovenous fistula

15. Patient has a diagnosed venous malformation

16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome

17. Patient has diagnosed BAVMs in context of moya-moya-type changes

18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference of 5-year event rates between two arms	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention	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)

Trial Locations

Locations (66)

Barrow Neurological Institute, 350 West Thomas Road; 🇺🇸 Phoenix, Arizona, United States

Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd; 🇺🇸 Los Angeles, California, United States

University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente (SF); 🇺🇸 Redwood City, California, United States

University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38; 🇺🇸 San Francisco, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700; 🇺🇸 Maywood, Illinois, United States

University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,; 🇺🇸 Iowa City, Iowa, United States

Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road; 🇺🇸 Southfield, Michigan, United States

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