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โ† Trials
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Chronic Subdural Hematoma Embolization With Detachable Coils

Recruitingn/aAges 18 Years - anyAllIcahn School of Medicine at Mount Sinai
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In plain words

What the trial is, and whether it could suit you

This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Age โ‰ฅ 18 * Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed. * A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study. * Signed informed consent obtained by patient or Legal Authorized Representative (LAR) Exclusion criteria: * Primary acute SDH * Prior MMAE in target territory * Premorbid mRS \> 3 * Common carotid stenosis \>70% or prior carotid stent placement * Significant medical contraindication to angiography (kidney failure/disease) * Anatomical variations that would make MMA embolization difficult or unsafe * Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints * Pregnancy * Life expectancy โ‰ค 1 year
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What it tests

  • Balt coils: (Balt USA, LLC)
  • MMA embolization
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Where

5 sites
Carondelet Neurological Institute
Tucson, United States
University of California - San Deigo
San Deigo, United States
John Muir Health
Walnut Creek, United States
University of Louisville
Louisville, United States
Oklahoma University Medical Center
Oklahoma City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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