Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

Patients with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Balt coils: (Balt USA, LLC)

    Device

    MMA embolization utilizing Balt Coils

  • MMA embolization

    Procedure/Surgery

    surgical or bedside evacuation pre or post-surgical debridement

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Participants with cSDH2 interventions

Trial outcomes

Primary outcomes

1

Change in hematoma volume

Change in hematoma volume based on CT imaging

Time frame
180 days
2

Change in maximal thickness

Change in maximal thickness based on CT imaging

Time frame
180 days
3

Change in midline shift

Change in midline shift (mm) based on CT imaging

Time frame
180 days
4

Number of periprocedural major disabling stroke or any death

Number of periprocedural major disabling stroke or any death

Time frame
30 days

Secondary outcomes

1

Number of Device-related adverse events (AE), serious adverse events (SAE), and procedural-related SAE

Number of Adverse events and serious adverse events related to the device as assessed by an independent medical monitor

Time frame
180 days
2

Number of Acute successful embolization of the target vessel

Determination of successful embolization based on angiographic imaging

Time frame
Immediately post-procedure
3

Change in EuroQoL 5 dimensions 5 levels (EQ-5D-5L)

The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L, each assessed on a 5-point scale (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems). Participants score each dimension based on their health that day and their responses are used to generate a health index score. Index scores could range from \<0 (a health state equivalent to dead with negative values representing a state worse than dead) to 1 (full health). Lower scores indicate a higher QoL.

Time frame
180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

John Muir Health

Collaborator

Carondelet Neurological Institute

Collaborator

Balt USA

Collaborator

Source ClinicalTrials.gov
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