Chronic Subdural Hematoma Embolization With Detachable Coils
ConditionChronic Subdural Hemorrhage (cSDH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 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)
Disqualifiers
Primary acute SDH
Prior MMAE in target territory
Premorbid mRS > 3
Common carotid stenosis >70% or prior carotid stent placement
Trial design
Treatments tested in this trial
- Balt coils: (Balt USA, LLC)
- MMA embolization
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
John Muir Health
Collaborator
Carondelet Neurological Institute
Collaborator
Source ClinicalTrials.gov